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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

    fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Us…

    Reason: Lack of Assurance of Sterility

    QuVa Pharma, Inc.

    Lots, distribution and details
    Product
    fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1259-75
    Lots / codes
    Lot, expiry: Lot 10140303, exp 04/14/2025; Lots 10140867, 10140868, exp 04/24/2025; Lot 10140965, exp 04/28/2025
    Distribution
    U.S. Nationwide
    Quantity
    1,765 cassettes
    Recall started
    March 6, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0297-2025
  • Class II Ongoing

    fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Offi…

    Reason: Lack of Assurance of Sterility

    QuVa Pharma, Inc.

    Lots, distribution and details
    Product
    fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75
    Lots / codes
    Lot, expiry: Lots 10140284, 10140285, 10140315, 10140316, exp 04/08/2025; Lot 10140510, exp 04/14/2025; Lot 10140916, exp 04/24/2025
    Distribution
    U.S. Nationwide
    Quantity
    2,310 cassettes
    Recall started
    March 6, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0296-2025
  • Class II Ongoing

    fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Us…

    Reason: Lack of Assurance of Sterility

    QuVa Pharma, Inc.

    Lots, distribution and details
    Product
    fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, Tx 77478. NDC: 70092-1255-75
    Lots / codes
    Lots: 10140259, 10140539, 10140687, 10140688; Exp 04/24/2025
    Distribution
    U.S. Nationwide
    Quantity
    N/A
    Recall started
    March 6, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0295-2025
  • Class II Completed

    Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02

    Reason: Presence of foreign substance: Presence of Benzene.

    Strides Pharma, Inc. · Testosterone

    Lots, distribution and details
    Lots / codes
    Lot #: 5501103A, Exp Mar-25; 5501237A, 5501238A, Exp Apr-25; 5501278A, Exp May-25; 5501280A, 5501342A, Exp Jun-25; 5501372A, Exp Jul-25; 5501496A, Exp Aug-25; 5501499A, Exp Sep-25; 5501580A, Exp Oct-25; 5501582A, Exp Dec-25; 5501653A, 5501656A, Exp Jan-26; 5501770A, Exp Feb-26; 5501842A, 5501868A, 5501882A, Exp Apr-26; 5501957A, Exp May-26; 5502001A, Exp Jul-26; 5502033A, Exp Aug-26; 5502112A, 5502115A, Exp Oct-26; 5502180A, 5502181A, Exp Nov-26.
    Distribution
    Nationwide in the U.S
    Quantity
    244,412 Cartons; 30 sachets /Carton
    Recall started
    March 5, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0294-2025
  • Class II Completed

    Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02

    Reason: Presence of foreign substance: Presence of Benzene.

    Strides Pharma, Inc. · Testosterone

    Lots, distribution and details
    Product
    Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02
    Lots / codes
    Lot #: 5501127A, 5501236A, Exp Apr-25; 5501341A, Exp Jun-25; 5501406A, Exp Jul-25; 5501408A, Exp Aug-25; 5501516A, Exp Sep-25; 5501568A, Exp Oct-25; 5501829A, Exp Mar-26; 5502000A, Exp Jul-26; 5502004A, 5502005A, Exp Aug-26; 5502092A, Exp Oct-26; 5502217A, Exp Dec-26; 5502262A, Exp Jan-27
    Distribution
    Nationwide in the U.S
    Quantity
    195,952 Cartons; 30 sachets/Carton.
    Recall started
    March 5, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0293-2025
  • Class II Completed

    METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3.

    Reason: Presence of Foreign Tablets/Capsules.

    A-S Medication Solutions LLC · Metformin Hydrochloride

    Lots, distribution and details
    Lots / codes
    Lot# 4260340; Exp.12/31/2025.
    Distribution
    Nationwide in U.S.
    Quantity
    411 180-count bottles
    Recall started
    February 25, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0292-2025
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-443-2…

    Reason: Super-Potent Drug: Out of specification potency results were obtained.

    Mylan Institutional, Inc. · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-443-20.
    Lots / codes
    Lot 3115773, Exp. 03/31/2025
    Distribution
    Nationwide in the USA
    Quantity
    1,068 cartons
    Recall started
    March 7, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0291-2025
  • Class II Ongoing

    Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-445-20…

    Reason: Super-Potent Drug: Out of specification potency results were obtained.

    Mylan Institutional, Inc. · Levothyroxine Sodium

    Lots, distribution and details
    Product
    Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-445-20.
    Lots / codes
    Lot 3116074, Exp. 09/30/2025
    Distribution
    Nationwide in the USA
    Quantity
    347 Cartons
    Recall started
    March 7, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0290-2025
  • Class II Ongoing

    CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www…

    Reason: Subpotent Drug

    MEDLINE INDUSTRIES, LP – Northfield

    Lots, distribution and details
    Product
    CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton, 30 Boxes per Case, Single Use Only, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093, USA, Made in India, www.curad.com, 1-800-633-5463, NDC 53329-827-30.
    Lots / codes
    SKU: CUR090737RB, Lot: 61224050002
    Distribution
    Nationwide
    Quantity
    1,639,996 pads
    Recall started
    February 17, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0289-2025
  • Class II Ongoing

    Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC…

    Reason: Subpotent Drug

    MEDLINE INDUSTRIES, LP – Northfield

    Lots, distribution and details
    Product
    Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Single Use Only, Large, www.medline.com, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, 1-800-MEDLINE, NDC 53329-811-30.
    Lots / codes
    SKU: MDS090670, Lot: 61224040057
    Distribution
    Nationwide
    Quantity
    6,669,874 pads
    Recall started
    February 17, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0288-2025
  • Class II Ongoing

    PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30

    Reason: Failed Dissolution Specifications

    Golden State Medical Supply Inc. · Prasugrel

    Lots, distribution and details
    Lots / codes
    Lot no's: GS059908, GS060228, GS060709, GS061233, GS061704, GS062158, GS062405, Exp.: 04/30/2026
    Distribution
    U.S. Nationwide
    Quantity
    2,601 30-count bottles
    Recall started
    March 5, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0287-2025
  • Class II Ongoing

    Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution – No Preservative, Amgen Inc. Thousand Oaks, CA 91320, NDC…

    Reason: Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.

    Amgen, Inc. · Filgrastim

    Lots, distribution and details
    Product
    Neupogen (filgrastim) For Injection, 480 mcg/1.6 mL (300 mcg/1 mL), 1.6 mL single Dose Vial, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution – No Preservative, Amgen Inc. Thousand Oaks, CA 91320, NDC 55513-546-01 (vial), NDC 55513-546-10 (box).
    Lots / codes
    Lot 1147308, 1154183, Exp.: 2/28/2025; 1156807, 1160222, Exp.: 6/30/2025; 1160223, 1163912, 1167352, Exp.: 2/28/2026; 1171365, 1175057, 1176250, Exp.: 11/30/2026.
    Distribution
    Nationwide in the U.S.A. and Belgium/Luxembourg, Brazil, Chile, Colombia, France/French Guiana, Germany, Ireland, Italy/San Marino, Netherlands, Poland, Spain/Andorra, Sweden, Finland, Switzerland/Liechtenstein, United Kingdom of Great Britain and Northern Ireland, Ireland, Denmark, Canada, Hong Kong, Philippines, Israel, Malaysia, Saudi Arabia, Gibraltar.
    Quantity
    258,750 Vials
    Recall started
    February 27, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0286-2025
  • Class II Ongoing

    Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution – No Preservative, Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-530-01 (vial…

    Reason: Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.

    Amgen, Inc. · Filgrastim

    Lots, distribution and details
    Product
    Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution – No Preservative, Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-530-01 (vial), NDC 55513-530-10 (box).
    Lots / codes
    Lot #: 1147300, 1147300A, Exp.: 2/28/2025; 1152064, Exp.:3/31/2025; 1154734, 1156806, Exp.: 8/31/2025; 1159109, Exp.: 10/31/2025; 1163909, Exp.: 2/28/2026; 1164631, Exp.: 5/31/2026; 1171366, 1182097, Exp.:8/31/2026; 1176114, Exp.: 2/28/2027; 1182094, Exp.:7/31/2027.
    Distribution
    Nationwide in the U.S.A. and Belgium/Luxembourg, Brazil, Chile, Colombia, France/French Guiana, Germany, Ireland, Italy/San Marino, Netherlands, Poland, Spain/Andorra, Sweden, Finland, Switzerland/Liechtenstein, United Kingdom of Great Britain and Northern Ireland, Ireland, Denmark, Canada, Hong Kong, Philippines, Israel, Malaysia, Saudi Arabia, Gibraltar.
    Quantity
    313,620 Vials
    Recall started
    February 27, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0285-2025
  • Class II Ongoing

    CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc

    Reason: Chemical contamination: presence of benzene

    Fruit Of The Earth, Inc.

    Lots, distribution and details
    Lots / codes
    Lot #: 4970743A, Exp 3/31/2026; 9712793A, Exp9/30/2026; 8363513B, Exp 12/31/2026; 1391304A, 5101574A, Exp 5/31/2027; 1292084A, 1292084B, 1292084C, Exp 7/31/2027; 2892384A, Exp 8/31/2027; 6203044A, 6203044B, Exp 10/31/2027; 2153564A, 2153564B, Exp 12/31/2027; 2163564A, Exp 1/31/2028
    Distribution
    USA Nationwide
    Quantity
    112045 tubes
    Recall started
    March 11, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0284-2025
  • Class II Ongoing

    Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a carton; Distributed by: Walgreen CO., 200 Wilmot Rd., Deerfield, IL 60015

    Reason: Chemical contamination: presence of benzene

    Fruit Of The Earth, Inc.

    Lots, distribution and details
    Lots / codes
    Lot #: 4970743B, 4970743C Exp 3/31/2026, 9722793A, Exp 9/30/2026; 8363513A, Exp 12/3/2026; 2822284A, Exp 8/31/2027; 2143554A, Exp 12/31/2027.
    Distribution
    USA Nationwide
    Quantity
    100,970 tubes
    Recall started
    March 11, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0283-2025
  • Class II Ongoing

    Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05

    Reason: Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

    FDC Limited · Ciprofloxacin

    Lots, distribution and details
    Lots / codes
    Lot: 084A067, Exp 12/31/2025
    Distribution
    Nationwide in the U.S
    Quantity
    90960 bottles
    Recall started
    March 11, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0282-2025
  • Class I Ongoing

    Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme Potency.

    Reason: Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.

    One Source Nutrition, Inc,

    Lots, distribution and details
    Lots / codes
    All lots
    Distribution
    Nationwide in the U.S.A
    Quantity
    a) 300 individually wrapped capsules b) 20 bottles
    Recall started
    February 20, 2025 (Voluntary: Firm initiated)
    Severity
    Most serious: use could cause serious health problems or death.
    FDA recall number
    D-0281-2025
  • Class II Ongoing

    Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93

    Reason: Failed Dissolution Specifications – low dissolution results

    MYLAN PHARMACEUTICALS INC · Prasugrel

    Lots, distribution and details
    Lots / codes
    Lot # 3211073, 3211074, 3211075, Exp 4/30/2026
    Distribution
    US Nationwide.
    Quantity
    N/A
    Recall started
    February 25, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0280-2025
  • Class II Completed

    Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04

    Reason: CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

    Slate Run Pharmaceuticals · Cinacalcet Hydrochloride

    Lots, distribution and details
    Lots / codes
    Lot # 109797, Exp 11/2026
    Distribution
    Product was distributed to 8 distributors who may have further distribute the product nationwide.
    Quantity
    2,444 bottles
    Recall started
    March 7, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0279-2025
  • Class II Completed

    Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04

    Reason: CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

    Slate Run Pharmaceuticals · Cinacalcet Hydrochloride

    Lots, distribution and details
    Lots / codes
    Lot # 07711, Exp 07/2025; 08900, Exp 09/2026; 08899, Exp 09/2026
    Distribution
    Product was distributed to 8 distributors who may have further distribute the product nationwide.
    Quantity
    56,790 bottles
    Recall started
    March 7, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0278-2025
  • Class II Ongoing

    Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99

    Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.

    Rising Pharma Holding, Inc. · Duloxetine

    Lots, distribution and details
    Lots / codes
    Lot #: DTB23111A, Exp 8/31/2025
    Distribution
    Nationwide in the USA.
    Quantity
    1223 bottles
    Recall started
    March 5, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0277-2025
  • Class II Ongoing

    Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ spray bottles, Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403, UPC 813277019923 and UPC 81…

    Reason: Chemical Contamination

    Johnson, S C and Son, Inc

    Lots, distribution and details
    Product
    Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ spray bottles, Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403, UPC 813277019923 and UPC 813277019916
    Lots / codes
    UPC 813277019916 Lot #: A033 / 5880343A, A054 / 2030633A, A058 / 2050633A, A058 / 2050633B, A058 / 2060633A, A058 / 2070633A, A058 / 2040633A, A059 / 2080633A, Exp. Date Feb-25; A314 / 4513223A, Exp. Date Nov-25; C054 / 2090774A, C057 / 2100774A, Exp. Date Feb-26; C131 / 3201394A, C131 / 3211394A, C131 / 3211394B, C131 / 3211394C, Exp. Date May-26 UPC 813277019923 Lot #: A060 / 3780693A, A060 / 3780693B, Exp. Date Mar-25; C067 / 2110774A, C067 / 2110774B, C067 / 2110774C, Exp. Date Mar-26; C169 / 7921734A, C169 / 7921734B, Exp. Date Jun-26
    Distribution
    Nationwide within the United States and Canada
    Quantity
    493,462 units
    Recall started
    February 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0276-2025
  • Class II Ongoing

    Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) packaged in a) 6 OZ (170 g) spray bottles UPC 813277019954 and UPC 813277019800; and b) Twinpack UPC 813277019930; Dist. by KAS Direct…

    Reason: Chemical Contamination

    Johnson, S C and Son, Inc

    Lots, distribution and details
    Product
    Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) packaged in a) 6 OZ (170 g) spray bottles UPC 813277019954 and UPC 813277019800; and b) Twinpack UPC 813277019930; Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403.
    Lots / codes
    a) UPC 813277019954 Lot #: A034 / 5810343A, A034 / 5820343A, Exp. Date Feb-25; A282 / 0122853A, A289 / 0132853A, Exp. Date Oct-25; C010 / 1680174A, C011 / 1690174A, Exp. Date Jan-26; C218 / 2592224A, C218 / 2602224A, Exp. Date Aug-26. UPC 813277019800 Lot #: A142 / 3901443A, A142 / 3911443A, A142 / 3921443A, Exp. Date May-25; A278 / 0142843A, A279 / 0152843A, A279 / 0162843A, Exp. Date Oct-25; A314 / 4473263A, A314 / 4483263A, A317 / 4493263A, Exp. Date Nov-25; C046 / 0100594A, C047 / 0110594A C050 / 0120594A, Exp. Date Feb-26; C068 / 2770774A, C071 / 2790774A, Exp. Date Mar-26; C102 / 9621154A, C102 / 9621154B, C102 / 9621154C, Exp. Date Apr-26; C144 / 4721534A, C144 / 4731534A, C144 / 4741534A, C144 / 4751534A, Exp. Date May-26 b) UPC 813277019930 Lot #: A033 / 5830343A, Exp. Date Feb-25; A079 / 9620893A, A079 / 9630893A, Exp. Date Mar-25; A142 / 3881453A, A142 / 3891453A, Exp. Date May-25
    Distribution
    Nationwide within the United States and Canada
    Quantity
    449,502 units
    Recall started
    February 13, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0275-2025
  • Class II Ongoing

    Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL, Made in Canada. UPC#: 1 9560203602 8

    Reason: Chemical Contamination: Presence of benzene

    Sigan Industries Group Inc.

    Lots, distribution and details
    Lots / codes
    Lot#: 23-09328, Exp.: 09/2025
    Distribution
    Nationwide in the U.S.A
    Quantity
    13,440 tubes
    Recall started
    February 28, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0274-2025
  • Class II Ongoing

    Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St Ste 200, Chattanooga, TN 37402. NDC 71687-0011-1

    Reason: Chemical Contamination: Presence of benzene.

    Denison Pharmaceuticals, LLC · Benzoyl Peroxide

    Lots, distribution and details
    Lots / codes
    Lot #: 9762, Exp. Date 2/28/2025; 9763, 9764, 9765, Exp. Date 3/31/2025; 9869, 9870, Exp. Date 5/31/2025; 9871, 9872, Exp. Date 7/31/2025; 9996, 9997, 9998, Exp. Date 8/31/2025; 9995, Exp. Date 10/31/2025; 0154, 0153, 0326, Exp. Date 1/31/2026; 0155, 0156, 0161, 0327, 0329, 0328, Exp. Date 2/28/2026; 0479, 0480, Exp. Date 5/31/2026.
    Distribution
    Nationwide within the USA
    Quantity
    642,131 tubes
    Recall started
    February 24, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0273-2025

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 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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