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.
3,228 recalls
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Class II Ongoing
ESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3037-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 253000125, Exp. 06/09/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 715 pellets
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0315-2026
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Class II Ongoing
ESTRADIOL, 25 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3025-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 253000136, Exp. 07/01/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 2,442 pellets.
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0314-2026
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Class II Ongoing
ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 253000126, Exp. 06/09/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 133 pellets
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0313-2026
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Class II Ongoing
ESTRADIOL, 20 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3020-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 253000124, Exp. 06/02/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 1,475 pellets
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0312-2026
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Class II Ongoing
ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 3521, NDC: 79559-3018-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 253000123, Exp. 06/02/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 1,699 pellets
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0311-2026
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Class II Ongoing
ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 253000118, Exp. 02/21/2026; 253000145, Exp. 08/02/2026; 253000146, Exp. 06/30/2026, 253000167, Exp. 09/23/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 14,848 pellets
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0310-2026
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Class II Ongoing
ESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 253000117, Exp. 02/21/2026; 253000129, Exp. 06/12/2026; 253000130, Exp. 06/16/2026; 253000154, 253000155, Exp. 08/29/2026; 253000160, Exp. 09/10/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 22,478 pellets.
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0309-2026
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Class II Ongoing
ESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 253000132, Exp. 06/16/2026; 253000139, 253000140, Exp. 07/21/2026; 253000150, Exp. 08/08/2026; 253000151, Exp. 08/16/2026; 253000161, 253000162, Exp. 09/12/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 24,099 pellets
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0308-2026
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Class II Ongoing
ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32.
Reason: Presence of Foreign substance – potential presence of metal particulate matter
Lots, distribution and details
- Lots / codes
- Lot#: 253000127, Exp. 06/09/2026; 253000133, Exp. 06/17/2026; 253000138, Exp. 07/14/2026; 253000141, Exp. 07/21/2026; 253000144, Exp. 07/28/2026; 253000147, Exp. 08/05/2026; 253000148, Exp. 08/07/2026; 253000149, Exp. 08/08/2026; 253000152, 253000153, Exp. 08/22/2026; 253000156, Exp. 09/03/2026; 253000157, Exp. 09/04/2026; 253000159, Exp. 09/05/2026; 253000164, Exp. 09/16/2026; 253000165, Exp. 09/19/2026; 253000170, Exp. 10/03/2026.
- Distribution
- Nationwide in the USA
- Quantity
- 50,990 pellets
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0307-2026
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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
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
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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
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
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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
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
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Class II Ongoing
Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1363-7
Reason: Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
Lots, distribution and details
- Lots / codes
- Lot # AD92721, Exp Date: 3/31/2027.
- Distribution
- US Nationwide.
- Quantity
- N/A
- Recall started
- January 27, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0342-2026
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Class I Ongoing
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313
Reason: CGMP Deviations: product found to contain lead.
Lots, distribution and details
- Lots / codes
- Lot: CAM040, Exp. 06/30/2029 Lot: CAL079-N, Exp. 09/30/2028
- Distribution
- Product was distributed to one customer in NY.
- Quantity
- 4 bottles /30 capsules each
- Recall started
- December 22, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0332-2026
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Class II Ongoing
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01.
Reason: Presence of Foreign Tablets/Capsules
Lots, distribution and details
- Lots / codes
- Batch # 6160008A, Exp Date: 12/31/2026
- Distribution
- US Nationwide.
- Quantity
- 71424 bottles.
- Recall started
- January 26, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0305-2026
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Class I Ongoing
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660
Reason: Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil
Lots, distribution and details
- Product
- Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660
- Lots / codes
- LOT308EXP03/28
- Distribution
- Nationwide
- Quantity
- N/A
- Recall started
- August 28, 2025 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0304-2026
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Class II Ongoing
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for:…
Reason: cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Lots, distribution and details
- Product
- Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01
- Lots / codes
- Lot # GBHL24005A, Exp Date: 09/2026
- Distribution
- US Nationwide and PR.
- Quantity
- N/A
- Recall started
- January 21, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0301-2026
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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
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
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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.
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
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Class II Ongoing
INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01
Reason: Failed Disintegration Specifications: above the time expected.
Lots, distribution and details
- Lots / codes
- Lot#: PWXT, Exp 1/31/2027
- Distribution
- CA and HI
- Quantity
- 3,640 bottles
- Recall started
- December 19, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0298-2026
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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.
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
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Class II Ongoing
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Reason: Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Lots, distribution and details
- Lots / codes
- Lot #: G171359, expiry: 05/31/2027
- Distribution
- Nationwide
- Quantity
- 125,496 bottles
- Recall started
- December 22, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0296-2026
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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
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
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Class II Ongoing
Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02
Reason: Subpotent Drug
Lots, distribution and details
- Lots / codes
- Lot #H22254-1XV; Exp. 01/31/2027
- Distribution
- U.S. Nationwide
- Quantity
- 58 gms
- Recall started
- January 16, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0294-2026
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Class II Ongoing
Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana – 502307, India, NDC 64980-563-…
Reason: Presence of Foreign Substance
Lots, distribution and details
- Product
- Furosemide Tablets, USP 40 mg, 1,000 Tablets, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., East Brunswick, NJ 08816, Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana – 502307, India, NDC 64980-563-10.
- Lots / codes
- Lot# FUB125042G; Exp. 05/13/2027
- Distribution
- U.S. Nationwide
- Quantity
- 4212 bottles
- Recall started
- January 10, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0293-2026
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 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.