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Drugs Recalls

Prescription and over-the-counter medications

17,685 Total Recalls

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.

Granules Pharmaceuticals

Class I - Dangerous

Presence of Foreign Tablets/Capsules

Jan 26, 2026 Prescription Drugs Nationwide View Details →

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

SUN PHARMACEUTICAL INDUSTRIES

Class I - Dangerous

Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.

Jan 27, 2026 Prescription Drugs Nationwide View Details →

Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313

HANDELNINE GLOBAL

Class I - Dangerous

CGMP Deviations: product found to contain lead.

Dec 22, 2025 Prescription Drugs View Details →

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

Haleon US Holdings

Class I - Dangerous

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

Dec 26, 2025 Other Drugs Nationwide View Details →

Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.

Baxter Healthcare

Class I - Dangerous

Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution

Dec 22, 2025 Prescription Drugs Nationwide View Details →

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

NOVADOZ PHARMACEUTICALS

Class I - Dangerous

Failed Impurities/Degradation Specifications

Dec 15, 2025 Prescription Drugs Nationwide View Details →

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

Greenstone

Class I - Dangerous

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.

Jan 15, 2026 Prescription Drugs Nationwide View Details →

INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count bottle, Manufactured by: Sato Pharmaceutical Co., Ltd., NDC 49873-402-01

Sato Pharmaceutical Co.

Class I - Dangerous

Failed Disintegration Specifications: above the time expected.

Dec 19, 2025 Prescription Drugs View Details →

Diclofenac 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

Cipla USA

Class I - Dangerous

Failed PH Specifications

Dec 22, 2025 Other Drugs Nationwide View Details →

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

Zydus Pharmaceuticals (USA)

Class I - Dangerous

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

Dec 30, 2025 Prescription Drugs Nationwide View Details →

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.

Graviti Pharmaceuticals Private Limited

Class I - Dangerous

Presence of Foreign Substance

Jan 10, 2026 Prescription Drugs Nationwide View Details →

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

Specialty Process Labs

Class I - Dangerous

Subpotent Drug

Jan 16, 2026 Prescription Drugs Nationwide View Details →

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

GOLD STAR DISTRIBUTION

Class I - Dangerous

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

Dec 26, 2025 Over-the-Counter Nationwide View Details →

LIQUID DAYQUIL 12/8oz

GOLD STAR DISTRIBUTION

Class I - Dangerous

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

Dec 26, 2025 Other Drugs Nationwide View Details →

EXCEDRIN MIGRAINE 2'S- 25 CT

GOLD STAR DISTRIBUTION

Class I - Dangerous

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

Dec 26, 2025 Other Drugs Nationwide View Details →

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

GOLD STAR DISTRIBUTION

Class I - Dangerous

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

Dec 26, 2025 Other Drugs Nationwide View Details →

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

GOLD STAR DISTRIBUTION

Class I - Dangerous

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

Dec 26, 2025 Other Drugs Nationwide View Details →

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

GOLD STAR DISTRIBUTION

Class I - Dangerous

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

Dec 26, 2025 Other Drugs Nationwide View Details →

Aleve 1's, 60 CT

GOLD STAR DISTRIBUTION

Class I - Dangerous

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

Dec 26, 2025 Other Drugs Nationwide View Details →

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

GOLD STAR DISTRIBUTION

Class I - Dangerous

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

Dec 26, 2025 Other Drugs Nationwide View Details →