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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.

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

1,070 recalls

  • Class III Ongoing

    Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulevard, Suite 2200, East Brunswick, NJ 08816 USA, manufactured by Unichem Laboratories…

    Reason: Tablets/Capsules Imprinted with Wrong ID

    Unichem Pharmaceuticals USA Inc. · Doxazosin Mesylate

    Lots, distribution and details
    Product
    Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulevard, Suite 2200, East Brunswick, NJ 08816 USA, manufactured by Unichem Laboratories Limited, Plot Number 15 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa (India) 403511, NDC 29300-353-10.
    Lots / codes
    Lot # GDSH25006, Exp Date: 08/2027
    Distribution
    Nationwide
    Quantity
    60,000 tablets
    Recall started
    January 21, 2026 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0306-2026
  • Class II Ongoing

    Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-112-11

    Reason: cGMP deviations

    Pro Numb Tattoo Numbing Spray LLC

    Lots, distribution and details
    Lots / codes
    Lot Number J15
    Distribution
    Nationwide in the USA
    Quantity
    N/A
    Recall started
    February 2, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0303-2026
  • Class II Ongoing

    Pro Numb Tattoo Numbing Spray, 5% Lidocaine, [1 FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-111-11

    Reason: cGMP deviations

    Pro Numb Tattoo Numbing Spray LLC

    Lots, distribution and details
    Lots / codes
    Lot Numbers J01 through J14, J55 through J69
    Distribution
    Nationwide in the USA
    Quantity
    N/A
    Recall started
    February 2, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0302-2026
  • Class III Ongoing

    Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceuticals Inc., Piscataway, NJ 08854, Distributed by: Novadoz Pharmaceuticals LLC, Piscataway, NJ 08854, NDC 72205-070-72

    Reason: Failed Impurities/Degradation Specifications

    NOVADOZ PHARMACEUTICALS LLC · Glycopyrrolate

    Lots, distribution and details
    Lots / codes
    Lot # CB2505159A, CB2505160A, Exp Date: 04/2027; Lot # CB2505161A, Exp Date: 05/2027
    Distribution
    US Nationwide.
    Quantity
    N/A
    Recall started
    December 15, 2025 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0300-2026
  • Class II Ongoing

    methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977. NDC 59762-4440-2

    Reason: Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.

    Greenstone Llc · Methylprednisolone

    Lots, distribution and details
    Lots / codes
    Lot # LG7675, Exp. Date Nov 2026
    Distribution
    Nationwide within the United States
    Quantity
    3456 cartons
    Recall started
    January 15, 2026 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0299-2026
  • Class III Ongoing

    parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL), Distributed by Haleon, Warren, NJ 07059. NDC 0135-0651-02

    Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.

    Haleon US Holdings LLC

    Lots, distribution and details
    Lots / codes
    Lot #: 0665363, Exp 08/31/2027. Lot number and Exp Date may not appear on the 500 mL bottle.
    Distribution
    Nationwide in the USA
    Quantity
    84,764 bottles
    Recall started
    December 26, 2025 (Voluntary: Firm initiated)
    Severity
    Not likely to cause health problems — for example a labelling or packaging fault.
    FDA recall number
    D-0297-2026
  • Class II Ongoing

    Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07

    Reason: Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules

    Zydus Pharmaceuticals (USA) Inc · Icosapent Ethyl

    Lots, distribution and details
    Lots / codes
    Lot # S2520304, S2520333, Exp 2/28/2027; S2540186, Exp 4/30/2027
    Distribution
    US Nationwide.
    Quantity
    22,896 bottles
    Recall started
    December 30, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0295-2026
  • Class II Ongoing

    Toothpaste: a) COLGATE, TOOTHPASTE, WHITENING, 2.5oz, 24ct; UPC: 035000511065; b) COLGATE, TOOTHPASTE, Regular, 2.5oz, 24ct, UPC: 035000511058; c) COLGATE, TOOTHPASTE, TRIPLE, 2.5oz, 24ct, UPC: 035000512109; d) COLGATE,…

    Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

    GOLD STAR DISTRIBUTION INC

    Lots, distribution and details
    Product
    Toothpaste: a) COLGATE, TOOTHPASTE, WHITENING, 2.5oz, 24ct; UPC: 035000511065; b) COLGATE, TOOTHPASTE, Regular, 2.5oz, 24ct, UPC: 035000511058; c) COLGATE, TOOTHPASTE, TRIPLE, 2.5oz, 24ct, UPC: 035000512109; d) COLGATE, TOOTHPASTE, MINT ZING, 24CT, 2.5oz, UPC: 035000744609; COLGATE, MAXFRESH, SPICY FRESH, RED TOOTH PASTE, 72CT, 150G; e) CREST, TOOTHPASTE, 40CT, 8.2OZ, UPC: 037000247081
    Lots / codes
    All lots within expiry distributed by Gold Star Distribution.
    Distribution
    US Nationwide.
    Quantity
    —
    Recall started
    December 26, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0287-2026
  • Class II Ongoing

    Deodorant: a) Axe, Body Spray, Wild Spice, 6CT, 150ML, UPC: 600108736469; b) LUCKY MENS STICK DEODORANT, SPRING FRESH, 24CT, 2.5 OZ, UPC: 808829111668; c) LUCKY MENS STICK DEODORANT, FRESH COMFORT, 24CT, 1.6 OZ, UPC: 808…

    Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

    GOLD STAR DISTRIBUTION INC

    Lots, distribution and details
    Product
    Deodorant: a) Axe, Body Spray, Wild Spice, 6CT, 150ML, UPC: 600108736469; b) LUCKY MENS STICK DEODORANT, SPRING FRESH, 24CT, 2.5 OZ, UPC: 808829111668; c) LUCKY MENS STICK DEODORANT, FRESH COMFORT, 24CT, 1.6 OZ, UPC: 808829089103; d) LADY DEODORANT, CHERRY BLOSSOSM, 24CT, 1.8oz, UPC: 048155921092; e) AXE, BODY SPRAY, APOLLO, 6CT, 150ML; f) AXE, BODY SPRAY, BLACK, 6CT, 150ML; g) AXE, BODY SPRAY, DARK TEMPTATION, 6CT, 150ML; h) AXE, BODY SPRAY, GOLD, 6CT, 150ML; i) AXE, BODY SPRAY, EXCITE, 6CT, 150ML; j) AXE, BODY SPRAY, ICE CHILL, 6CT, 150ML; k) AXE, BODY SPRAY, MUSK, 6CT, 150ML; l) AXE, DEODORANT SPRAY, ADRENALIN, 6CT, 150ML
    Lots / codes
    All lots within expiry distributed by Gold Star Distribution.
    Distribution
    US Nationwide.
    Quantity
    —
    Recall started
    December 26, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0286-2026
  • Class II Ongoing

    Petroleum jelly: a) Vaseline Petroleum Jelly, 1.75, 12CT, UPC: 6001085120946; b) Vaseline Men Cooling Petroleum Jelly, 100ML, 12CT, UPC: 60022141; c) Vaseline Vitamin E, Petroleum Jelly, 100ML, 12CT, UPC: 6001085121028;…

    Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

    GOLD STAR DISTRIBUTION INC

    Lots, distribution and details
    Product
    Petroleum jelly: a) Vaseline Petroleum Jelly, 1.75, 12CT, UPC: 6001085120946; b) Vaseline Men Cooling Petroleum Jelly, 100ML, 12CT, UPC: 60022141; c) Vaseline Vitamin E, Petroleum Jelly, 100ML, 12CT, UPC: 6001085121028; MEN FRESH PETROLEUM JELLY, 100ML, 12CT, UPC: 60022127; d) Lucky Petroleum Jelly, 6 OZ, 12 PK, UPC: 808829081466;048155903562; e) Lucky Petroleum Jelly, COCOA, 6oz, 12ct, UPC: 808829081572, 048155922150; f) Personal Care, CREAMY PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155908642; g) Personal Care, CREAMY COCOA PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155922242; h) SOFTEE, PETROLEUM JELLY, 5oz, 12CT, UPC: 096002007208
    Lots / codes
    All lots within expiry distributed by Gold Star Distribution.
    Distribution
    US Nationwide.
    Quantity
    Unknown
    Recall started
    December 26, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0285-2026
  • Class II Ongoing

    LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989

    Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

    GOLD STAR DISTRIBUTION INC

    Lots, distribution and details
    Lots / codes
    All lots within expiry distributed by Gold Star Distribution.
    Distribution
    US Nationwide.
    Quantity
    Unknown
    Recall started
    December 26, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0284-2026
  • Class II Ongoing

    Personal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319

    Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

    GOLD STAR DISTRIBUTION INC

    Lots, distribution and details
    Lots / codes
    All lots within expiry distributed by Gold Star Distribution.
    Distribution
    US Nationwide.
    Quantity
    Unknown
    Recall started
    December 26, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0283-2026
  • Class II Ongoing

    Carmex a) jar, 12 count, UPC: 083078123154, 083078113155; b) Tube, PEG, 12 count, UPC: 083078123147, 083078113148

    Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

    GOLD STAR DISTRIBUTION INC

    Lots, distribution and details
    Lots / codes
    All lots within expiry distributed by Gold Star Distribution.
    Distribution
    US Nationwide.
    Quantity
    Unknown
    Recall started
    December 26, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0282-2026
  • Class II Ongoing

    Personal Care, Ice Gel, 8oz, 12 count, UPC 048155903463

    Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

    GOLD STAR DISTRIBUTION INC

    Lots, distribution and details
    Lots / codes
    All lots within expiry distributed by Gold Star Distribution.
    Distribution
    US Nationwide.
    Quantity
    Unknown
    Recall started
    December 26, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0281-2026
  • Class II Ongoing

    Swan, White Clear Alcohol, 50%, 16oz, 12 count

    Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

    GOLD STAR DISTRIBUTION INC

    Lots, distribution and details
    Lots / codes
    All lots within expiry distributed by Gold Star Distribution.
    Distribution
    US Nationwide.
    Quantity
    Unknown
    Recall started
    December 26, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0280-2026
  • Class II Ongoing

    TUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #1194A *05/27; c)Extra Strength (EX) Assorted Fruit, 12-count, #1194C *03/27

    Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

    GOLD STAR DISTRIBUTION INC

    Lots, distribution and details
    Lots / codes
    All lots within expiry distributed by Gold Star Distribution.
    Distribution
    US Nationwide.
    Quantity
    —
    Recall started
    December 26, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0279-2026
  • Class II Ongoing

    Halls Cough Drops a) BAGS, MENTHOL, 12CT; b) BAGS, HONEY LEM, 12CT; c) BAGS, DEFENSE CITRUS, 12CT; d) BAGS, CHERRY, 12CT; e) M. CHERRY, 20 STK; f) BRAZIL, Cherry, 21CT/27.5G; f) LEMON. HONEY, 20CT #1180E; g) LIME FRESH,…

    Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

    GOLD STAR DISTRIBUTION INC

    Lots, distribution and details
    Product
    Halls Cough Drops a) BAGS, MENTHOL, 12CT; b) BAGS, HONEY LEM, 12CT; c) BAGS, DEFENSE CITRUS, 12CT; d) BAGS, CHERRY, 12CT; e) M. CHERRY, 20 STK; f) BRAZIL, Cherry, 21CT/27.5G; f) LEMON. HONEY, 20CT #1180E; g) LIME FRESH, 20CT, #1182; h) MENTHOL BLUE, 20CT, #1180A; i) BRAZIL, Menthol, 21CT/27.5G, j) M . STRAWBERRY, 20 STK; k) DEFENSE, VITAMIN C, 20CT, #1181
    Lots / codes
    All lots within expiry distributed by Gold Star Distribution.
    Distribution
    US Nationwide.
    Quantity
    —
    Recall started
    December 26, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0278-2026
  • Class II Ongoing

    TYLENOL a) 500 MG., 2'S DISPLAY, 50CT; b) COLD & FLU, 25CT/2S; c) COLD & FLU SEVERE, 2PK, 50CT; d) PM, 50CT; e) SINUS SEVERE, 2PK, 50CT

    Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

    GOLD STAR DISTRIBUTION INC

    Lots, distribution and details
    Lots / codes
    All lots within expiry distributed by Gold Star Distribution.
    Distribution
    US Nationwide.
    Quantity
    —
    Recall started
    December 26, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0277-2026
  • Class II Ongoing

    PEPCID COMPLETE – 25CT

    Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

    GOLD STAR DISTRIBUTION INC

    Lots, distribution and details
    Lots / codes
    All lots within expiry distributed by Gold Star Distribution.
    Distribution
    US Nationwide.
    Quantity
    —
    Recall started
    December 26, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0276-2026
  • Class II Ongoing

    PEPTO BISMOL 32CT

    Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

    GOLD STAR DISTRIBUTION INC

    Lots, distribution and details
    Lots / codes
    All lots within expiry distributed by Gold Star Distribution.
    Distribution
    US Nationwide.
    Quantity
    —
    Recall started
    December 26, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0275-2026
  • Class II Ongoing

    CHILDREN NYQUIL, COLD&FLU, BERRY, 8oz, 12ct

    Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

    GOLD STAR DISTRIBUTION INC

    Lots, distribution and details
    Lots / codes
    All lots within expiry distributed by Gold Star Distribution.
    Distribution
    US Nationwide.
    Quantity
    —
    Recall started
    December 26, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0274-2026
  • Class II Ongoing

    NYQUIL COLD & FLU -32CT/2PK

    Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

    GOLD STAR DISTRIBUTION INC

    Lots, distribution and details
    Lots / codes
    All lots within expiry distributed by Gold Star Distribution.
    Distribution
    US Nationwide.
    Quantity
    —
    Recall started
    December 26, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0273-2026
  • Class II Ongoing

    LIQUID NYQUIL a) regular, 12/8oz; b) cherry, 12/8oz

    Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

    GOLD STAR DISTRIBUTION INC

    Lots, distribution and details
    Lots / codes
    All lots within expiry distributed by Gold Star Distribution.
    Distribution
    US Nationwide.
    Quantity
    —
    Recall started
    December 26, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0272-2026
  • Class II Ongoing

    MOTRIN 2'S DISP.- 50CT

    Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

    GOLD STAR DISTRIBUTION INC

    Lots, distribution and details
    Lots / codes
    All lots within expiry distributed by Gold Star Distribution.
    Distribution
    US Nationwide.
    Quantity
    —
    Recall started
    December 26, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0271-2026
  • Class II Ongoing

    EXCEDRIN MIGRAINE 2'S- 25 CT

    Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

    GOLD STAR DISTRIBUTION INC

    Lots, distribution and details
    Lots / codes
    All lots within expiry distributed by Gold Star Distribution.
    Distribution
    US Nationwide.
    Quantity
    —
    Recall started
    December 26, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0270-2026

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 1, 2026 02:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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