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Drug Recalls

Last updated

Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.

3 Class I (most serious) drug recalls reported in the last 30 days.

1,094 recalls

  • Class II Ongoing

    Hydrogen Peroxide 16 fl. oz. and 32 oz. bottles distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

    Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.

    Family Dollar Stores, Llc.

    Lots, distribution and details
    Lots / codes
    SKUs: 909221, 901675
    Distribution
    Nationwide within the United States
    Quantity
    Unknown
    Recall started
    June 23, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1369-2022
  • Class II Ongoing

    Listerine Cool mint Mouthwash 250 mL SKU 900733 Crest Scope Outlast Mint Mouthwash 1 Liter SKU 902704 Swan Mouthwash Green Mint 1 LTR SKU 908114 Colgate Peroxyl Antiseptic Mouth Sore Rinse 8.4 FL OZ SKU 998273 Listerine…

    Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.

    Family Dollar Stores, Llc.

    Lots, distribution and details
    Product
    Listerine Cool mint Mouthwash 250 mL SKU 900733 Crest Scope Outlast Mint Mouthwash 1 Liter SKU 902704 Swan Mouthwash Green Mint 1 LTR SKU 908114 Colgate Peroxyl Antiseptic Mouth Sore Rinse 8.4 FL OZ SKU 998273 Listerine Cool Mint Mouthwash 50.72 FL OZ SKU 999050 Swan Spring Mint Antiseptic Mouth Rinse 8.5 OZ SKU 900273 Swan Original Antiseptic Mouth Rinse 8.5 OZ SKU 900938 Colgate Optic White Mouthwash 16 FL OZ SKU 999043 Crest Scope Classic Original Min Mouthwash 1 Ltr SKU 908109 Listerine Cool Mint Mouthwash 500 mL SKU 908223 Act Kids Bubble Gum Blowout Mouthwash 16.9 Fl OZ SKU 999935 Swan Ice Mint Antiseptic Mouth Rinse 8.5 OZ SKU 903150 Swan Mouthwash Cool Mint 1 Liter SKU 908466 Crest Mouthwash Pro Health Multi Protection Mint 1 Liter SKU 908123, Colgate Mouthwash Total Advanced Peppermint Blast 1 Liter SKU 903156 Listerine Total Care Freshmine 1 Liter SKU 900980 Listerine Ultra Clean Cool Mint 1 Liter SKU 901904 Listerine Mouthwash Freshburst 1 Liter SKU 903159 Listerine Mouthwas Original Amber 1 Liter SKU 908004 Listerine Mouthwash Coolmint 1 Liter SKU 908005 Swan Antiseptic Rinse Amber 1 Liter SKU 908465 Crest Scope Mouthwash All Day 1 Liter SKU 998269 Listerine Mouthwash Coolmint 95 Milliliters SKU 999752 Swan Fresh Mint Mouthwash 1 Liter SKU 999762 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Lots / codes
    SKUs: 900733; 902704; 908114; 998273; 999050; 900273; 900938; 999043; 908109; 908223; 999935; 903150; 908466; 908123; 903156; 900980; 901904; 903159; 908004; 908005; 908465; 998269; 999752; 999762
    Distribution
    Nationwide within the United States
    Quantity
    Unknown.
    Recall started
    June 23, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1368-2022
  • Class II Ongoing

    COLGATE MAX FRESH CLEAN MINT 1.9OZ SKU 900596 COLGATE CAVITY PROTECTION 6OZ 3PK SKU 900734 SENSODYNE REPAIR AND PROTCT WHITNG 3.4 OZ SKU 901003 COLGATE BSPW PASTE BRISK MINT 6 OZ 2PK SKU 901658 COLGATE MAX FRESH COOL MIN…

    Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.

    Family Dollar Stores, Llc.

    Lots, distribution and details
    Product
    COLGATE MAX FRESH CLEAN MINT 1.9OZ SKU 900596 COLGATE CAVITY PROTECTION 6OZ 3PK SKU 900734 SENSODYNE REPAIR AND PROTCT WHITNG 3.4 OZ SKU 901003 COLGATE BSPW PASTE BRISK MINT 6 OZ 2PK SKU 901658 COLGATE MAX FRESH COOL MINT 6OZ 2PK SKU 901785 COLGATE BSPW PASTE 6 OZ 3PK SKU 902143 CREST CMPLT SCOPE OUTLST PSTE 5.4OZ 2 PK SKU 902701 COLGATE TOTAL WHITENING TP 4.8 OZ SKU 902967 CREST 3D WHITE BRILLIANCE CHARCOAL 3.9 OZ SKU 903463 COLGATE BSPW GEL FROSTY MINT 6 OZ SKU 905026 ARM & HAMMER COMPLETE CARE BKS PRX TP 6 OZ SKU 905028 COLGATE BSPW PASTE BRISK MINT 2.5 OZ SKU 905703 COLGATE BSPW PASTE BRISK MINT 6 OZ SKU 907121 CREST BS N PX WHTE TUBE FRESH MINT 5.7 OZ SKU 907125 COLGATE SPARKLING WHITE MINT ZING 2.5 OZ SKU 907151 ARM & HAMMERADV WHITE TP 4.3 FL OZ SKU 907766 COLGATE MAX FRESH COOL MINT TP 6 OZ SKU 907839 CREST COMPLETE SCOPE OUTLAST TP 5.4 OZ SKU 907872 COLG MAX FRESH COOL MINT TP 6.3 OZ 3PK SKU 998200 COLGATE OW STAIN FIGHTR TOOTHPASTE 4.2 OZ SKU 998278 COLGATE MAX FRESH WHTNING CHRCOAL TP 6 OZ SKU 998881 COLGATE CHARCOAL TP 2.2 OZ SKU 998902 CREST 3D WHITE STAIN ERASER 3.1OZ TWN PK SKU 999286 COLGATE ESSENTIALS CHARCOAL PASTE 4.6 OZ SKU 999318 COLGATE TOTAL CLEANMINT TOOTHPASTE 4.8 OZ SKU 999498 COLGATE OW STAINFIGHTERCLEANMNT4.2OZ 2PK SKU 999633 COLGATE OW STAIN FIGHTER CLEAN MNT 4.2 OZ SKU 999750 COLGATE DEEP CLEAN GEL TOOTHPASTE 2.5 OZ SKU 999916 CREST TARTAR PROTECTION PASTE 5.7 OZ SKU 900353 COLGATE TOTAL WHITENING GEL 4.8OZ 2 PK SKU 903152 CREST CAVITY PROTECTION PASTE 5.7 OZ SKU 907327 CREST PRO HEALTH WHITENING GEL TP 4.6 OZ SKU 999760 AIM CAVITY PRTCT MINT GEL 4.5 OZ SKU 999910 CREST 3D WHITE RADIANT MINT 2.7 OZ SKU 907160 CR FRESH WHT PEP GIM 2.4 OZ SKU 900791 COLGATE SENSITIVE WHITENING PASTE 6 OZ SKU 901677 COLGATE TRIPLE ACTION 2.5 OZ SKU 907170 COLGATE OW STAIN PREVENTION TP 2.1 OZ SKU 998277 CREST 3D WHITE CHARCOAL 2.7 OZ SKU 999282 ARM & HAMMER PEROXICARE MINT PASTE 6 OZ SKU 999937 CREST ANTI CAVITY PASTE 2.4 OZ SKU 907165 CLOSE UP CINN RED GEL TP 4 OZ SKU 907220 COLGATE BSPW GEL TP 6OZ 3PK; SKU 902966 COLGATE TOTAL WHTN GEL TP 4.8 OZ SKU 906406 COLGATE CAVITY PROTECTION 6 OZ SKU 907329 COLGATE MAX FRSH ADV WHTN CLN MNT TP 6 OZ SKU 998257 CG OW SF MINT PASTE 2.0 OZ SKU 999723 COLGATE KIDS JUNIOR BUBBLE FRUIT 3.5 OZ SKU 900592 CREST BKING SDA PEROXIDE WHTNG TP 2.4 OZ SKU 907865 CREST KIDS SPRKL TPST 2.2 OZ SKU 901243 CREST 3D WHITE ARTIC FRESH 2.7 OZ SKU 905045 COLGATE RENEWAL GUM REVITALIZE TP 3 OZ SKU 998741 ULTRA BRITE ADV WHITENING TP 6 OZ SKU 902134 COLGATE BASE DEEP CLEAN GEL 6 OZ SKU 900728 COLGATE TOTAL WHTN PASTE TP 4.8OZ 2PK SKU 901784 SENSODYNE PRO NAMELGENTLE WHT 2.7 OZ SKU 902124 SWAN ULTRA CLEAN ARCTIC MINT 33.8 FL OZ SKU 902840 CREST 3DW ULTRA WHITE 3 OZ SKU 903453 COLGATE KIDS TP ASRTD CHARACTERS 4.6 OZ SKU 905517 PEPSODENT ORIGINAL TP 4.5 OZ SKU 907136 SENSODYNE EXTRA WHTEN TP 2.7 OZ SKU 907781 CREST PSTE DNSIFY DAILY WHITENING 4.1 OZ SKU 998268 ORAJEL PP FLUORIDE TOOTHPASTE 4.2 OZ SKU 998397 CREST 3D WHITE BRILLIANCE THPASTE 2.7 OZ SKU 998730 TOM'S KIDS STRAWBERRY ANTICAVITY 5.1 OZ SKU 999099 CREST 3D WHITE STNERSR ICY CLN MNT 3.1 OZ SKU 999285 SENSODYNE COMPLETE FRESH PASTE 3.4 OZ SKU 902363 CREST PRO HEALTH DEEP CLEAN TP 3.5 OZ SKU 903245 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Lots / codes
    SKUs: 900596, 900734, 901003, 901658, 901785, 902143, 902701, 902967, 903463, 905026, 905028, 905703, 907121, 907125, 907151, 907766, 907839, 907872, 998200, 998278, 998881, 998902, 999286, 999318, 999498, 999633, 999750, 999916, 900353, 903152, 907327, 999760, 999910, 907160, 900791, 901677, 907170, 998277, 999282, 999937, 907165, 907220, 902966, 906406, 907329, 998257, 999723, 900592, 907865, 901243, 905045, 998741, 902134, 900728, 901784, 902124, 902840, 905517, 907136, 907781, 998268, 998397, 998730, 999099, 999285, 902363, 903245, 903453
    Distribution
    Nationwide within the United States
    Quantity
    Unknown
    Recall started
    June 23, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1367-2022
  • Class II Ongoing

    Dermasil Dry Skin Treatment 10 OZ SKU 2098068 Aveeno Daily Moisturizing Lotion 5 OZ SKU 2005444 Aveeno Baby Daily Moistue Lotion 8 OZ SKU 900016 Vaseline Mens Extra Strength Body and Face Lotion 10 OZ SKU 2003674 distrib…

    Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.

    Family Dollar Stores, Llc.

    Lots, distribution and details
    Product
    Dermasil Dry Skin Treatment 10 OZ SKU 2098068 Aveeno Daily Moisturizing Lotion 5 OZ SKU 2005444 Aveeno Baby Daily Moistue Lotion 8 OZ SKU 900016 Vaseline Mens Extra Strength Body and Face Lotion 10 OZ SKU 2003674 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Lots / codes
    SKUs: 2098068, 2005444, 900016, 2003674
    Distribution
    Nationwide within the United States
    Quantity
    Unknown
    Recall started
    June 23, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1366-2022
  • Class II Ongoing

    BANANA BOAT SPRT CLR SPRY SPF50 6 FL OZ SKU 2007524 SUNTONE SPORT SPRAY SPF 50 5.5 OZ SKU 2096102 HAWAIIAN TROPIC TANNING OIL SPRAY PUMP SPF 25 8 FL OZ SKU 2096111 BANANA BOAT SPORT ULTRAMIST SPRAY SPF 65 6 OZ SKU 209611…

    Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.

    Family Dollar Stores, Llc.

    Lots, distribution and details
    Product
    BANANA BOAT SPRT CLR SPRY SPF50 6 FL OZ SKU 2007524 SUNTONE SPORT SPRAY SPF 50 5.5 OZ SKU 2096102 HAWAIIAN TROPIC TANNING OIL SPRAY PUMP SPF 25 8 FL OZ SKU 2096111 BANANA BOAT SPORT ULTRAMIST SPRAY SPF 65 6 OZ SKU 2096117 COPPERTONE WATERBABIES LOTION SPF 50 8 FL OZ SKU 2097635 COPPERTONE SPORT SPRAY SPF 50 5.5 OZ SKU 2097636 BANANA BOAT SPRT LTION SPF 50 8 FL OZ SKU 2099592 HAWAIIAN TROPIC SHEER TOUCH LOTION SPF 30 8 FL OZ SKU 2006432 BB KIDS SUN SCREEN MIST SPRAY SPF 100 6 OZ SKU 2007523 SUNTONE KIDS SPRAY SPF 50 6 OZ SKU 2096096 NEUTROGENA BCH DFNSE SPR SPF 70 SKU 2097632 BANANA BOAT KDS SPRT SPRY SPF50 6FL OZ SKU 2097655 BANANA BOAT DRY OIL MST SPRY 15 SPF 6 OZ SKU 2097794 BANANA BOAT TAN DRY OIL MIST 4 SPF 6 OZ SKU 2097144 COPPERTONE GLOW SPRAY SPF 50 5OZ SKU 2096124 COPPERTONE SPORT LOTION SPF 50 8.75 FLOZ SKU 2096130 NEUTROGENA ULTRA SHEER LOTN SPF 55 3 FL OZ SKU 2097637 SUNTONE KIDS LOTION SPF 50 6 FL OZ SKU 2096101 BANANA BOAT SPORT ULTRA MIST 30 SPF 6 OZ SKU 2097141 COPPERTONE SPORT SPRAY SPF30 5.5OZ SKU 2097083 SUNTONE SPORT SPRAY SPF 70 5.5 OZ SKU 2008234 SUNTONE SPORT LOTION SPF 50 6 FL OZ SKU 2096099 COPPERTONE KIDS SPRAY SPF 50 5.5 OZ SKU 2097084 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Lots / codes
    SKUs: 2007524, 2096102, 2096111, 2096117, 2097635, 2097636, 2099592, 2007523, 2096096, 2097632, 2097655, 2097794, 2097144, 2096124, 2096130, 2097637, 2096101, 2097141, 2097083, 2008234, 2096099, 2097084; 2006432
    Distribution
    Nationwide within the United States
    Quantity
    Unknown
    Recall started
    June 23, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1365-2022
  • Class II Ongoing

    AMBI Skin Cream for normal skin 2 OZ SKU 2024219 AMBI Skin Cream for oily skin 2 OZ SKU 2024222. distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

    Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.

    Family Dollar Stores, Llc.

    Lots, distribution and details
    Product
    AMBI Skin Cream for normal skin 2 OZ SKU 2024219 AMBI Skin Cream for oily skin 2 OZ SKU 2024222. distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Lots / codes
    SKUs: 2024219; 2024222
    Distribution
    Nationwide within the United States
    Quantity
    Unknown
    Recall started
    June 23, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1364-2022
  • Class II Ongoing

    Novelty Hand Sanitizer with Silicone Wrap SKU 998890 Novelty Hand Sanitizer Assorted SKU 999330 Purell Hand Sanitizer Essentials 1 FL OZ SKU 2006819 Luxury Hand Sanitizer 16.9 FL OZ SKU 2007723 Suave Hand Sanitizer Lotio…

    Reason: CGMP Deviations: product held outside appropriate storage temperature conditions.

    Family Dollar Stores, Llc.

    Lots, distribution and details
    Product
    Novelty Hand Sanitizer with Silicone Wrap SKU 998890 Novelty Hand Sanitizer Assorted SKU 999330 Purell Hand Sanitizer Essentials 1 FL OZ SKU 2006819 Luxury Hand Sanitizer 16.9 FL OZ SKU 2007723 Suave Hand Sanitizer Lotion 3 FL OZ SKU 2096469 Purell Hand Sanitizer Original 6.5 FL OZ SKU 2095985 Purell Hand Sanitizer Soothing Aloe 6.5 Fluid Ounces SKU 2095986 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
    Lots / codes
    SKUs: 998890; 999330; 2006819; 2007723; 2096469; 2095985; 2095986
    Distribution
    Nationwide within the United States
    Quantity
    Unknown
    Recall started
    June 23, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-1363-2022
  • Class II Ongoing

    Aveeno Daily Moisturizing lotion Fragrance Free with Soothing Oat & Rich Emollients, Net Wt. 5 oz (141 g), Distributed by Johnson & Johnson Consumer, Inc. Skillman, NJ 08558, UPC 3 81137-001530 7

    Reason: cGMP deviations: product stored outside of labeled temperature requirements.

    Family Dollar Stores, Llc.

    Lots, distribution and details
    Lots / codes
    SKUs 2005444
    Distribution
    USA Nationwide
    Quantity
    Unknown
    Recall started
    May 17, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0981-2022
  • Class II Ongoing

    Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 3814…

    Reason: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

    McKesson Corporation dba McKesson Drug Company · Erythromycin

    Lots, distribution and details
    Product
    Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-053-68
    Lots / codes
    Lot: 15723, Exp.: 06/30/2022
    Distribution
    Nationwide in the United States including Guam and the Northern Mariana Islands.
    Quantity
    5,640 tubes
    Recall started
    April 21, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0851-2022
  • Class II Ongoing

    Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sk…

    Reason: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

    McKesson Corporation dba McKesson Drug Company · Betamethasone Dipropionate

    Lots, distribution and details
    Product
    Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-65
    Lots / codes
    Lot: 15644, Exp.: 05/31/2022
    Distribution
    Nationwide in the United States including Guam and the Northern Mariana Islands.
    Quantity
    55,440 tubes
    Recall started
    April 21, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0850-2022
  • Class II Ongoing

    Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Teligent Pharma, Inc., B…

    Reason: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

    McKesson Corporation dba McKesson Drug Company

    Lots, distribution and details
    Product
    Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, NDC 63739-054-66
    Lots / codes
    Lot: 16876, Exp.: 05/31/2023
    Distribution
    Nationwide in the United States including Guam and the Northern Mariana Islands.
    Quantity
    1176 tubes
    Recall started
    April 21, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0849-2022
  • Class II Ongoing

    Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suit…

    Reason: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

    McKesson Corporation dba McKesson Drug Company

    Lots, distribution and details
    Product
    Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-977-64
    Lots / codes
    Lots: 15597, Exp.: 05/31/2023; 16305, Exp.: 12/23/2023; 16334, Exp.: 01/31/2024; 16340, Exp.: 01/31/2024; 16346 Exp.: 01/31/2024; 16356, Exp.: 01/31/2024; 16357, Exp.: 01/31/2024
    Distribution
    Nationwide in the United States including Guam and the Northern Mariana Islands.
    Quantity
    81,757 bottles
    Recall started
    April 21, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0848-2022
  • Class II Ongoing

    Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphi…

    Reason: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

    McKesson Corporation dba McKesson Drug Company

    Lots, distribution and details
    Product
    Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-998-67
    Lots / codes
    Lots: 15720, Exp.: 06/30/2022; 16449 Exp.: 02/28/2023; 16450, Exp.: 02/26/2023
    Distribution
    Nationwide in the United States including Guam and the Northern Mariana Islands.
    Quantity
    13, 200 tubes
    Recall started
    April 21, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0847-2022
  • Class II Ongoing

    All Over-The-Counter (OTC) drug products sold by Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee.

    Reason: CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center.

    Dollar Tree Distribution, Inc.

    Lots, distribution and details
    Lots / codes
    All drug products sold by Family Dollar retail stores located in AL, AR, LA, MS, MO, and TN from January 1, 2021 to present.
    Distribution
    Alabama, Arkansas, Louisiana, Mississippi, Missouri, Tennessee
    Quantity
    Unknown
    Recall started
    February 18, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0641-2022
  • Class II Ongoing

    Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.

    Reason: Labeling – product contains undeclared ethyl alcohol

    Tsm Brands LLC

    Lots, distribution and details
    Lots / codes
    Lot#:339,340,341,342,343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,377,378,379,380,381,382,383,384,385,386,387,388,389,390,391,392,393,394,395,396,397,398 and 399
    Distribution
    USA Nationwide
    Quantity
    135.444 bottles
    Recall started
    February 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0636-2022
  • Class II Ongoing

    70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 ML bottle, Distributed By: TSM Brands LLC, 540 Equinox LN, Manalapan, NJ 07726, www.tsmbrands.com, Made in Turkey, UPC 868275965765

    Reason: Labeling – product contains undeclared ethyl alcohol

    Tsm Brands LLC

    Lots, distribution and details
    Lots / codes
    Lot#: 39,40,41,42,43,44 and 45
    Distribution
    USA Nationwide
    Quantity
    1.186.800 bottles
    Recall started
    February 7, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0635-2022
  • Class II Ongoing

    Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50

    Reason: CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.

    Mayne Pharma Inc

    Lots, distribution and details
    Product
    Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50
    Lots / codes
    Lot #: 32451 Exp. 03/2022; 32532 Exp. 04/2022; 32552 Exp. 05/2022; 32701 32733 Exp. 10/2022; 32855 Exp. 02/2023; 32872 Exp. 03/2023.
    Distribution
    Nationwide within the United States
    Quantity
    17,113 canisters
    Recall started
    January 14, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0387-2022
  • Class II Ongoing

    Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging,…

    Reason: Superpotent Drug: Minimally superpotent

    Teligent Pharma, Inc. · Lidocaine Hydrochloride

    Lots, distribution and details
    Product
    Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64
    Lots / codes
    Lot #: 15594, Exp Date 05/2023
    Distribution
    Distributed to a wholesaler in CO who further distributed Nationwide in the USA
    Quantity
    7,176 bottles
    Recall started
    November 30, 2021 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0296-2022
  • Class I Ongoing

    Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging,…

    Reason: Superpotent Drug

    Teligent Pharma, Inc. · Lidocaine Hydrochloride

    Lots, distribution and details
    Product
    Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64
    Lots / codes
    Lot #: 16345, Exp. Date 01/2024
    Distribution
    Distributed to a wholesaler in CO who further distributed Nationwide in the USA
    Quantity
    6,816 bottles
    Recall started
    November 30, 2021 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0295-2022
  • Class II Ongoing

    Meclizine HCl Tablets, 25 mg, packaged in 100-count HDPE bottle, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816, Manufactured by: Aurex laboratories LLC, East Windsor, NJ 08520, NDC 16571-752-01

    Reason: Labeling: Incorrect Instructions

    RISING PHARMACEUTICALS · Meclizine Hydrochloride

    Lots, distribution and details
    Lots / codes
    Lot # CB21024, Exp 2/2023
    Distribution
    to be entered
    Quantity
    1,344 bottles
    Recall started
    September 2, 2021 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0005-2022
  • Class I Ongoing

    ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003…

    Reason: Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil

    Alpha-Tek LLC

    Lots, distribution and details
    Product
    ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton)
    Lots / codes
    All lots within expiry
    Distribution
    Nationwide in the US
    Quantity
    Unknown
    Recall started
    July 16, 2021 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0001-2022
  • Class II Ongoing

    Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%) NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & J…

    Reason: cGMP Deviations

    Johnson & Johnson Consumer, Inc.

    Lots, distribution and details
    Product
    Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%) NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11255 6
    Lots / codes
    All lots within expiry
    Distribution
    Nationwide in US
    Quantity
    N/A
    Recall started
    July 14, 2021 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0850-2021
  • Class II Ongoing

    Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 6.5 OZ. (184 g) aerosol can, Distributed by: JOHNSON & J…

    Reason: cGMP Deviations

    Johnson & Johnson Consumer, Inc.

    Lots, distribution and details
    Product
    Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 6.5 OZ. (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11254 9
    Lots / codes
    All lots within expiry
    Distribution
    Nationwide in US
    Quantity
    N/A
    Recall started
    July 14, 2021 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0849-2021
  • Class II Ongoing

    Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & J…

    Reason: cGMP Deviations

    Johnson & Johnson Consumer, Inc.

    Lots, distribution and details
    Product
    Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858 UPC 0 86800 10048 5
    Lots / codes
    All lots within expiry
    Distribution
    Nationwide in US
    Quantity
    411,180 cans
    Recall started
    July 14, 2021 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0848-2021
  • Class II Ongoing

    Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), Net Wt. 8.0 oz. (226 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC.…

    Reason: cGMP Deviations

    Johnson & Johnson Consumer, Inc.

    Lots, distribution and details
    Product
    Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), Net Wt. 8.0 oz. (226 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858 UPC 0 86800 11133 7
    Lots / codes
    All lots within expiry
    Distribution
    Nationwide in US
    Quantity
    196,380 cans
    Recall started
    July 14, 2021 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0847-2021

Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.

What the recall classes mean

  • Class I Most serious: use could cause serious health problems or death.
  • Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
  • Class III Not likely to cause health problems — for example a labelling or packaging fault.

Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update November 4, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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