Class III drugs recalls – page 2

• Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister… recall
  FDA November 5, 2025 · Endo USA, Inc. · Class III
• Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister… recall
  FDA November 5, 2025 · Endo USA, Inc. · Class III
• Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister… recall
  FDA November 5, 2025 · Endo USA, Inc. · Class III
• Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips… recall
  FDA November 5, 2025 · Endo USA, Inc. · Class III
• Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604 recall
  FDA November 5, 2025 · Letco Medical LLC · Class III
• Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles… recall
  FDA October 29, 2025 · JB Chemicals and Pharmaceuticals Ltd · Class III
• Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles… recall
  FDA October 29, 2025 · JB Chemicals and Pharmaceuticals Ltd · Class III
• Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips… recall
  FDA October 22, 2025 · Endo USA, Inc. · Class III
• FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL… recall
  FDA October 22, 2025 · STAQ Pharma, Inc. · Class III
• Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use… recall
  FDA October 22, 2025 · STAQ Pharma, Inc. · Class III
• Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use… recall
  FDA October 22, 2025 · STAQ Pharma, Inc. · Class III
• READYPREP PVP, Povidone-Iodine 10% Solution, Topical Antiseptic… recall
  FDA October 1, 2025 · Medline Industries, LP · Class III
• Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate… recall
  FDA October 1, 2025 · Granules Pharmaceuticals Inc. · Class III
• Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate… recall
  FDA October 1, 2025 · Granules Pharmaceuticals Inc. · Class III
• Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate… recall
  FDA October 1, 2025 · Granules Pharmaceuticals Inc. · Class III
• Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate… recall
  FDA October 1, 2025 · Granules Pharmaceuticals Inc. · Class III
• Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate… recall
  FDA October 1, 2025 · Granules Pharmaceuticals Inc. · Class III
• TopCare Health 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can… recall
  FDA October 1, 2025 · Consumer Product Partners, LLC · Class III
• Kroger 70% Isopropyl Alcohol, NET WT 5.5 OZ (156 g) per can… recall
  FDA October 1, 2025 · Consumer Product Partners, LLC · Class III
• Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496 recall
  FDA September 10, 2025 · Boothwyn Pharmacy LLC · Class III
• Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations… recall
  FDA August 27, 2025 · Cipla USA, Inc. · Class III
• Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active… recall
  FDA August 27, 2025 · Haleon US Holdings LLC · Class III
• Tropicamide-Proparacaine-Phenylephrine-Ketorolac… recall
  FDA July 30, 2025 · Imprimis NJOF, LLC · Class III
• Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only… recall
  FDA July 23, 2025 · Qualgen, LLC · Class III
• Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only… recall
  FDA July 16, 2025 · Macleods Pharmaceuticals Ltd · Class III
• Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only… recall
  FDA July 9, 2025 · AvKARE · Class III
• Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only… recall
  FDA July 9, 2025 · AvKARE · Class III
• Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets… recall
  FDA July 9, 2025 · Orient Pharma Co., Ltd. Yunlin Plant · Class III
• Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets… recall
  FDA July 9, 2025 · Orient Pharma Co., Ltd. Yunlin Plant · Class III
• Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets… recall
  FDA June 18, 2025 · Macleods Pharmaceuticals Ltd · Class III
• Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only… recall
  FDA June 18, 2025 · Glenmark Pharmaceuticals Inc., USA · Class III
• HYDROmorphone Hydrochloride 50mg/50mL (1mg/mL)… recall
  FDA April 30, 2025 · OurPharma LLC · Class III
• Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles recall
  FDA April 16, 2025 · Sun Pharmaceutical Industries Inc · Class III
• Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles recall
  FDA April 16, 2025 · Sun Pharmaceutical Industries Inc · Class III
• Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic… recall
  FDA April 9, 2025 · Imprimis NJOF, LLC · Class III
• Tolterodine Tartrate Extended-Release Capsules, 2 mg… recall
  FDA April 9, 2025 · Major Pharmaceuticals and Rugby Laboratories · Class III
• Livalo (pitavatstatin) tablets, 4 mg, 90-count bottles, Rx only… recall
  FDA March 19, 2025 · Kowa Pharmaceuticals America · Class III
• Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL… recall
  FDA February 12, 2025 · Pharmaceutical Associates Inc · Class III
• BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC… recall
  FDA February 5, 2025 · The W.S. Badger Company, Inc. · Class III
• Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets… recall
  FDA January 29, 2025 · Appco Pharma LLC · Class III
• Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma… recall
  FDA January 22, 2025 · Akron Pharma, Inc. · Class III
• Diphenhydramine HCl 25 mg, 1000 Capsules per bottle, Akron Pharma… recall
  FDA January 22, 2025 · Akron Pharma, Inc. · Class III
• Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma… recall
  FDA January 22, 2025 · Akron Pharma, Inc. · Class III
• Acetaminophen Extra Strength 500 mg, 1000 Tablets per bottle… recall
  FDA January 22, 2025 · Akron Pharma, Inc. · Class III
• Acetaminophen, 325 mg Tablets, 100 Tablets per bottle, Akron Pharma… recall
  FDA January 22, 2025 · Akron Pharma, Inc. · Class III
• Acetaminophen Regular Strength, 325 mg, 100 Tablets per bottle… recall
  FDA January 22, 2025 · Akron Pharma, Inc. · Class III
• Acetaminophen Extra Strength 500 mg, 100 Tablets per bottle, Akron Pharma… recall
  FDA January 22, 2025 · Akron Pharma, Inc. · Class III
• Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets… recall
  FDA January 15, 2025 · West-Ward Columbus Inc · Class III
• Polyvinyl Alcohol Ophthalmic Solution 1.4%… recall
  FDA January 8, 2025 · AvKARE · Class III
• Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing… recall
  FDA January 8, 2025 · AvKARE · Class III
• Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only… recall
  FDA January 8, 2025 · Somerset Therapeutics LLC · Class III
• Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle… recall
  FDA December 18, 2024 · Dr. Reddy's Laboratories, Inc. · Class III
• Varithena (polidocanol injectable foam) Administration Pack… recall
  FDA December 18, 2024 · Biocompatibles UK, Ltd. · Class III
• Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg… recall
  FDA December 11, 2024 · Zydus Pharmaceuticals (USA) Inc · Class III
• Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only… recall
  FDA November 27, 2024 · Padagis US LLC · Class III
• IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr recall
  FDA November 27, 2024 · Dr. Reddy's Laboratories, Inc. · Class III
• Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton… recall
  FDA November 20, 2024 · Major Pharmaceuticals and Rugby Laboratories · Class III
• Kids' Cough and Chest Congestion (Dextromethorphan HBr… recall
  FDA November 13, 2024 · Denison Pharmaceuticals, LLC · Class III
• Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg… recall
  FDA November 13, 2024 · Denison Pharmaceuticals, LLC · Class III
• Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes… recall
  FDA October 9, 2024 · Glenmark Pharmaceuticals Inc., USA · Class III