Drug and pharmaceutical recalls
17622 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2026-02-18FDA-DrugF.H. INVESTMENTS, Inc. (dba Asteria Health)Class IIESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.
Presence of Foreign substance - potential presence of metal particulate matter
- 2026-02-18FDA-DrugF.H. INVESTMENTS, Inc. (dba Asteria Health)Class IIESTRADIOL, 12.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79599-3012-32.
Presence of Foreign substance - potential presence of metal particulate matter
- 2026-02-18FDA-DrugF.H. INVESTMENTS, Inc. (dba Asteria Health)Class IIESTRADIOL, 10 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3010-32.
Presence of Foreign substance - potential presence of metal particulate matter
- 2026-02-18FDA-DrugF.H. INVESTMENTS, Inc. (dba Asteria Health)Class IIESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3006-32.
Presence of Foreign substance - potential presence of metal particulate matter
- 2026-02-18FDA-DrugUnichem Pharmaceuticals USA Inc.Class IIIDoxazosin 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.
Tablets/Capsules Imprinted with Wrong ID
- 2026-02-18FDA-DrugPro Numb Tattoo Numbing Spray LLCClass IIPro 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
cGMP deviations
- 2026-02-18FDA-DrugPro Numb Tattoo Numbing Spray LLCClass IIPro 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
cGMP deviations
- 2026-02-11FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIDiclofenac 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
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
- 2026-02-11FDA-DrugHANDELNINE GLOBAL LLCClass IRheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313
CGMP Deviations: product found to contain lead.
- 2026-02-11FDA-DrugGranules Pharmaceuticals Inc.Class IITrazodone 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.
Presence of Foreign Tablets/Capsules
- 2026-02-11FDA-DrugGreen Lumber Holdings, LLCClass IGreen 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
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil
- 2026-02-11FDA-DrugUnichem Pharmaceuticals USA Inc.Class IIBisoprolol 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
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
- 2026-02-04FDA-DrugNOVADOZ PHARMACEUTICALS LLCClass IIIGlycopyrrolate 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
Failed Impurities/Degradation Specifications
- 2026-02-04FDA-DrugGreenstone LlcClass IImethylprednisolone 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
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.
- 2026-02-04FDA-DrugSato Pharmaceutical Co., LtdClass IIINON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01
Failed Disintegration Specifications: above the time expected.
- 2026-02-04FDA-DrugHaleon US Holdings LLCClass IIIparodontax (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
Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.
- 2026-02-04FDA-DrugBaxter Healthcare CorporationClass IISterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
- 2026-01-28FDA-DrugZydus Pharmaceuticals (USA) IncClass IIIcosapent 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
Subpotent Drug: Due to oxidation caused by leakage of the contents of the capsules
- 2026-01-28FDA-DrugSpecialty Process Labs LLCClass IIThyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02
Subpotent Drug
- 2026-01-28FDA-DrugGraviti Pharmaceuticals Private LimitedClass IIFurosemide 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.
Presence of Foreign Substance
- 2026-01-28FDA-DrugCipla USA, Inc.Class IIIDiclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd., 307 E Josephine Street, San Antonio, TX 78215. NDC: 76282-103-39
Failed PH Specifications
- 2026-01-21FDA-DrugCipla USA, Inc.Class IILanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67
Presence of Particulate Matter.
- 2026-01-21FDA-DrugGOLD STAR DISTRIBUTION INCClass IIToothpaste: 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
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- 2026-01-21FDA-DrugGOLD STAR DISTRIBUTION INCClass IIDeodorant: 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, 1
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- 2026-01-21FDA-DrugGOLD STAR DISTRIBUTION INCClass IIPetroleum 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)
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- 2026-01-21FDA-DrugGOLD STAR DISTRIBUTION INCClass IILUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- 2026-01-21FDA-DrugGOLD STAR DISTRIBUTION INCClass IIPersonal Care, Vaporizing Chest Rub, 4 oz, 12 count, UPC 048155903319
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- 2026-01-21FDA-DrugGOLD STAR DISTRIBUTION INCClass IICarmex a) jar, 12 count, UPC: 083078123154, 083078113155; b) Tube, PEG, 12 count, UPC: 083078123147, 083078113148
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- 2026-01-21FDA-DrugGOLD STAR DISTRIBUTION INCClass IIPersonal Care, Ice Gel, 8oz, 12 count, UPC 048155903463
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
- 2026-01-21FDA-DrugGOLD STAR DISTRIBUTION INCClass IISwan, White Clear Alcohol, 50%, 16oz, 12 count
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
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