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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.

3,250 recalls

  • Class II Ongoing

    buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 60687-782-01.

    Reason: Failed Dissolution Specifications; the product is dissolving faster than the specified limits.

    Amerisource Health Services LLC

    Lots, distribution and details
    Lots / codes
    Lot 1017343, Exp. 12/31/2025
    Distribution
    Nationwide in the USA
    Quantity
    2,484 cartons
    Recall started
    June 24, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0590-2024
  • Class II Ongoing

    suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, a) NDC: 69949-151-01, UPC: 854245006170 – IVORY b)…

    Reason: CGMP Deviations

    SYNCHRONICITY SPA INC, DBA SUNTE

    Lots, distribution and details
    Product
    suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, a) NDC: 69949-151-01, UPC: 854245006170 – IVORY b) NDC: 69949-156-01, UPC: 854245006224 – NUDE c) NDC: 69949-152-01, UPC: 854245006187 – BUFF d) NDC: 69949-153-01, UPC: 854245006194 – SAND e) NDC: 69949-155-01, UPC: 854245006217 – BRONZE f) NDC: 69949-157-01, UPC: 854245006446 – MOCHA
    Lots / codes
    Lot: a) 107IV, Exp: 04/30/2025 b) 107NU, Exp: 06/30/2025; 109NU, Exp: 10/31/2025 c) 117BU, Exp: 10/31/2025 d) 113SA, Exp: 06/30/2025; 114SA, Exp: 10/31/2025 e) 106BR, Exp: 04/30/2025; f) 101MO, Exp: 05/31/2025
    Distribution
    Distributed Nationwide in the USA and Queensland, Christchurch, Ontario, Quebec, Alberta, British Columbia Cayman Islands, Bermuda, France, Amsterdam, Hants, Dubai, Hong Kong, Singapore, Taiwan
    Quantity
    8202 tubes
    Recall started
    May 24, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0589-2024
  • Class I Ongoing

    suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187

    Reason: Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)

    SYNCHRONICITY SPA INC, DBA SUNTE

    Lots, distribution and details
    Product
    suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187
    Lots / codes
    Lot#: 115BU, Exp: 06/30/2025;
    Distribution
    Distributed Nationwide in the USA and Queensland, Christchurch, Ontario, Quebec, Alberta, British Columbia Cayman Islands, Bermuda, France, Amsterdam, Hants, Dubai, Hong Kong, Singapore, Taiwan
    Quantity
    1,902 tubes
    Recall started
    May 24, 2024 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0588-2024
  • Class II Ongoing

    Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-0…

    Reason: Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.

    Baxter Healthcare Corporation

    Lots, distribution and details
    Product
    Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01
    Lots / codes
    Lot R24B25FA; Exp. 2/28/2026
    Distribution
    US Nationwide, Canada
    Quantity
    6,874 bags
    Recall started
    June 17, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0587-2024
  • Class I Ongoing

    To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026

    Reason: Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.

    Integrity Products

    Lots, distribution and details
    Product
    To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026
    Lots / codes
    Lot HGW221116 (Batch 022123-1), Exp 5/31/2025
    Distribution
    Nationwide in the USA
    Quantity
    2500 boxes
    Recall started
    February 1, 2024 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0586-2024
  • Class I Ongoing

    RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026

    Reason: Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.

    Integrity Products

    Lots, distribution and details
    Lots / codes
    Lot HGW221116 (Batch 020123-1), Exp 5/31/2025
    Distribution
    Nationwide in the USA
    Quantity
    2500 boxes
    Recall started
    February 1, 2024 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0585-2024
  • Class II Terminated

    Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Major Pharmaceutical 17177 N Laurel Park D…

    Reason: Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.

    The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Venlafaxine Hydrochloride

    Lots, distribution and details
    Product
    Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Major Pharmaceutical 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, USA, NDC 0904-7075-61, UPC code: 309047075614
    Lots / codes
    Lot code: M04614, Exp 09/30/2024
    Distribution
    Nationwide. No foreign consignees.
    Quantity
    864 cartons
    Recall started
    June 18, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0584-2024
  • Class II Terminated

    Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106 USA, NDC 55111-730-01.

    Reason: Presence of foreign substance.

    Dr. Reddy's Laboratories, Inc. · Allopurinol

    Lots, distribution and details
    Lots / codes
    L2300594
    Distribution
    IL, MS, OH
    Quantity
    20,520 units
    Recall started
    June 7, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0583-2024
  • Class II Ongoing

    Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pha…

    Reason: CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.

    SUN PHARMACEUTICAL INDUSTRIES INC

    Lots, distribution and details
    Product
    Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-361-40.
    Lots / codes
    HAD2964A, Exp 7/31/2024
    Distribution
    Nationwide in the USA
    Quantity
    2088 vials
    Recall started
    July 2, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0582-2024
  • Class III Ongoing

    Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally – 500 090 INDIA, NDC 55111-629-30

    Reason: Failed Impurities/Degradation Specifications: Related Substances

    Dr. Reddy's Laboratories, Inc. · Eszopiclone

    Lots, distribution and details
    Lots / codes
    Lot#: C2302598, Exp 2/29/2025
    Distribution
    OH, MS
    Quantity
    13,752 bottles
    Recall started
    June 4, 2024 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0581-2024
  • Class III Terminated

    Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 21…

    Reason: Subpotent drug: out of specification results

    Accord Healthcare, Inc.

    Lots, distribution and details
    Product
    Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India, NDC 16729-533-08, UPC Code: 031672953308
    Lots / codes
    Lot# R2200834, R2200835, R2200841, R2200958, Exp 06/30/2024; R2201044 R2201045 R2201046, R2201047, R2201095, R2201142, R2201143, R2201144, Exp 07/31/2024; M2215870, M2215918, Exp 10/2024
    Distribution
    USA Nationwide
    Quantity
    52,998
    Recall started
    June 18, 2024 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0580-2024
  • Class II Terminated

    Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10

    Reason: Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.

    Trigen Laboratories · Methylphenidate Hydrochloride

    Lots, distribution and details
    Lots / codes
    Lot 230159M, Exp Date 2/28/2026
    Distribution
    Nationwide in the USA
    Quantity
    10,448 100-count bottles
    Recall started
    June 17, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0579-2024
  • Class II Ongoing

    Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) Packaged as a) 2 FL OZ (60ML) spray bottle, UPC Code 6 73673 88797 3, NDC 70722-319-02; b) 4 FL OZ (118ML) spray bottle, UPC Code 6 73673 88798…

    Reason: CGMP deviations

    Little Moon Essentials LLC

    Lots, distribution and details
    Product
    Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) Packaged as a) 2 FL OZ (60ML) spray bottle, UPC Code 6 73673 88797 3, NDC 70722-319-02; b) 4 FL OZ (118ML) spray bottle, UPC Code 6 73673 88798 0, NDC 70722-319-04; Little Moon Essentials LLC Dania Beach, Fl 33004
    Lots / codes
    lot code expiration dates are not on products: a) 023170, b) 023170
    Distribution
    Nationwide USA and Ontario, Canada (2 retailers)
    Quantity
    20 spray bottles
    Recall started
    June 20, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0578-2024
  • Class II Ongoing

    Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88227 5, NDC 70722-216-05; b) 3 OZ (85-05G) metal tin UPC Code 6 73673 88216 9, NDC 70722-216-…

    Reason: CGMP deviations

    Little Moon Essentials LLC

    Lots, distribution and details
    Product
    Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88227 5, NDC 70722-216-05; b) 3 OZ (85-05G) metal tin UPC Code 6 73673 88216 9, NDC 70722-216-03; Little Moon Essentials LLC Dania Beach, Fl 33004
    Lots / codes
    lot code no expiration date on product: a) 322230, 424040, b) 322230, 325070, 324080, 325180, 325280, 328290, 426110, 423210, 426120, 422220, 423130, 428230, 325040
    Distribution
    Nationwide USA and Ontario, Canada (2 retailers)
    Quantity
    320 metal tins
    Recall started
    June 20, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0577-2024
  • Class II Ongoing

    Little Moon Essentials, Ass Kisser, Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88228 2, NDC 70722-208-05; b) 3 OZ (85.05G) metal tin, UPC Code 6 73673 88208 4, NDC 70722-208-03; Little Moon Essentials LLC Da…

    Reason: CGMP deviations

    Little Moon Essentials LLC

    Lots, distribution and details
    Product
    Little Moon Essentials, Ass Kisser, Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88228 2, NDC 70722-208-05; b) 3 OZ (85.05G) metal tin, UPC Code 6 73673 88208 4, NDC 70722-208-03; Little Moon Essentials LLC Dania Beach, Fl 33004
    Lots / codes
    lot code no expiration date on product: a) 327140, b) 322170, 325040, 325250
    Distribution
    Nationwide USA and Ontario, Canada (2 retailers)
    Quantity
    165 metal tins
    Recall started
    June 20, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0576-2024
  • Class II Ongoing

    Little Moon Essentials, Vital Vapor Balm, (Camphor 0.6%, Menthol 5.2%) Packaged as a) 0.5OZ (14G) metal tin, UPC Code 6 73673 88231 2, NDC 70722-229-05) b) 2OZ (57G) glass jar, UPC Code 6 73673 88220 6, NDC 70722-229-02;…

    Reason: CGMP deviations

    Little Moon Essentials LLC

    Lots, distribution and details
    Product
    Little Moon Essentials, Vital Vapor Balm, (Camphor 0.6%, Menthol 5.2%) Packaged as a) 0.5OZ (14G) metal tin, UPC Code 6 73673 88231 2, NDC 70722-229-05) b) 2OZ (57G) glass jar, UPC Code 6 73673 88220 6, NDC 70722-229-02; c) 4OZ (113G) glass jar, UPC Code 6 73673 88218 3, NDC 70722-229-04; Little Moon Essentials LLC Dania Beach, Fl 33004
    Lots / codes
    lot code no expiration date on product: a) 324280, b) 328230, 321170, 321290, 326021, 420220, 422140, c) 326040, 328170
    Distribution
    Nationwide USA and Ontario, Canada (2 retailers)
    Quantity
    1041
    Recall started
    June 20, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0575-2024
  • Class II Ongoing

    Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as a) 2OZ (57G) glass jar, UPC Code 6 73673 88214 5, NDC 70722-232-02; b) 4OZ (113G) glass jar, UPC Code 6 73673 88804 8, NDC 70722-232-04; Little…

    Reason: CGMP deviations

    Little Moon Essentials LLC

    Lots, distribution and details
    Product
    Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as a) 2OZ (57G) glass jar, UPC Code 6 73673 88214 5, NDC 70722-232-02; b) 4OZ (113G) glass jar, UPC Code 6 73673 88804 8, NDC 70722-232-04; Little Moon Essentials LLC Dania Beach, Fl 33004
    Lots / codes
    lot code no expiration dates on product: a) 328260, 321221, 425120, 427230, b) 327150, 326260, 320270, 321301, 422020
    Distribution
    Nationwide USA and Ontario, Canada (2 retailers)
    Quantity
    1264 glass jars
    Recall started
    June 20, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0574-2024
  • Class II Ongoing

    Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0.5OZ (14G), metal tin, UPC Code 67367388226 8, NDC 70722-203-05; b)1OZ (28G) glass jar, UPC Code 6 73673 88203 9, NDC 70722-203-01; Little Moon…

    Reason: CGMP deviations

    Little Moon Essentials LLC

    Lots, distribution and details
    Product
    Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0.5OZ (14G), metal tin, UPC Code 67367388226 8, NDC 70722-203-05; b)1OZ (28G) glass jar, UPC Code 6 73673 88203 9, NDC 70722-203-01; Little Moon Essentials LLC Dania Beach, Fl 33004
    Lots / codes
    lot code No expiration date on product: a) 326070, 420140, b) 322030, 321230, 329230, 321240, 329170, 328280, 326090, 322290, 327021, 323121, 327221, 429210, 424130, 427050
    Distribution
    Nationwide USA and Ontario, Canada (2 retailers)
    Quantity
    6,312 tin and glass jars
    Recall started
    June 20, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0573-2024
  • Class II Ongoing

    Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 88260 2, NDC 70722-260-04; b) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88204 6, NDC 70722-260-02, Litt…

    Reason: CGMP deviations

    Little Moon Essentials LLC

    Lots, distribution and details
    Product
    Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 88260 2, NDC 70722-260-04; b) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88204 6, NDC 70722-260-02, Little Moon Essentials LLC Dania Beach, Fl 33004
    Lots / codes
    lot code No Expiration Date on product: a) 224010, b) 321260, 322260, 320280, 328080, 325021, 321121, 423010, 427110, 429120, 420220, 422140
    Distribution
    Nationwide USA and Ontario, Canada (2 retailers)
    Quantity
    788 glass jars
    Recall started
    June 20, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0572-2024
  • Class II Ongoing

    Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) packaged as: a) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88202 2, NDC 70722-246-02; b) 4 FL OZ (118ML) jar, UPC Code 6 73673 88233 6, NDC 70722…

    Reason: CGMP deviations

    Little Moon Essentials LLC

    Lots, distribution and details
    Product
    Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) packaged as: a) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88202 2, NDC 70722-246-02; b) 4 FL OZ (118ML) jar, UPC Code 6 73673 88233 6, NDC 70722-246-04; Little Moon Essentials LLC Dania Beach, Fl 33004
    Lots / codes
    lot code No expiration date on product: a) 325240, 320260, 329011, 324021, 328221, 421110, 422120, 423120, 421220, 426220, 428220, b) 329230, 328140, 320290, 328011.
    Distribution
    Nationwide USA and Ontario, Canada (2 retailers)
    Quantity
    1654 glass jars
    Recall started
    June 20, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0571-2024
  • Class II Completed

    Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.

    Reason: CGMP Deviations and Presence of Particulate Matter: Glass

    Medisca Inc. · Budesonide

    Lots, distribution and details
    Lots / codes
    Lot #s: 202323/G, 202323/H, Exp. 07/31/2026
    Distribution
    Nationwide in the USA and Canada
    Quantity
    113 bottles
    Recall started
    June 26, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0570-2024
  • Class III Ongoing

    SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12 Hour Relief, 0.5 fl oz (15 ml) bottle, Manufactured by NeilMed Pharmaceuticals Inc, 602 Aviation Blv…

    Reason: Sub-potent Drug

    Neilmed Pharmaceuticals Inc

    Lots, distribution and details
    Product
    SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12 Hour Relief, 0.5 fl oz (15 ml) bottle, Manufactured by NeilMed Pharmaceuticals Inc, 602 Aviation Blvd, Santa Rosa, CA 95403 877-477-8633; NDC 13709-325-01; UPC 7 05928 09001 9.
    Lots / codes
    Lot: SD134; Exp: 10/31/2026
    Distribution
    Nationwide in the US
    Quantity
    20,370 bottles
    Recall started
    June 24, 2024 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0569-2024
  • Class II Terminated

    Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Pack…

    Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.

    Golden State Medical Supply Inc. · Duloxetine

    Lots, distribution and details
    Product
    Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
    Lots / codes
    Lot: a) GS045371, Exp: 01/31/2025; b) GS045910, Exp. 01/31/2025
    Distribution
    Nationwide in the U.S.
    Quantity
    21,655 (30 count bottle), 34,149 (90 count bottle)
    Recall started
    May 13, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0568-2024
  • Class II Ongoing

    Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-003-01 (carton) NDC 65250-001-01 (vial) wi…

    Reason: Failed Dissolution Specifications – did not meet the acceptance criteria for IVR Level 3 testing at 9 months 2-8¿C followed by 6 weeks at 25¿C

    PACIRA PHARMACEUTICALS INC

    Lots, distribution and details
    Product
    Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pacira Pharmaceuticals Inc., San Diego, CA 92121, NDC 65250-003-01 (carton) NDC 65250-001-01 (vial) with Diluent 5 mL Sterile single-use vial, Rx Only, Mfd. for: Pacira Pharmaceuticals, Inc. NDC 65250-002-01
    Lots / codes
    Lot 23-9006; Expiry Date: MAR 2025
    Distribution
    US Nationwide.
    Quantity
    40,517 kits
    Recall started
    June 12, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0567-2024
  • Class II Ongoing

    Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233, Livonia, MI USA 48152, NDC 0904-6730-60, UPC Number 309046730606

    Reason: Discoloration: Brownish tablets

    Contract Pharmacal Corporation

    Lots, distribution and details
    Lots / codes
    Lot#: 368638; Exp. 05/2025
    Distribution
    MI
    Quantity
    14,616 bottles
    Recall started
    May 20, 2024 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0566-2024

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 3, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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