enforcement database
FDA Drug Recalls
462 documented actions on record. FDA recalls of pharmaceutical products, including OTC and prescription drugs.
- Total actions
- 462
- Earliest on record
- January 11, 2023
- Most recent
- August 19, 2026
- Source
- openFDA (recall)
Severity breakdown
- Critical29
- High386
- Medium47
Most recent drug recalls (30 of 462 shown)
- Buy-Herbal — Class I recall: Kian Pee Wan Capsules, 30-count bottles
August 19, 2026·Critical
- Apollo Care, LLC — Class II recall: SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose…
August 19, 2026·High
- Apollo Care, LLC — Class II recall: SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose V…
August 19, 2026·High
- Apollo Care, LLC — Class II recall: SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcut…
August 19, 2026·High
- Apollo Care, LLC — Class II recall: SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutan…
August 19, 2026·High
- Novartis Pharmaceuticals Corporation — Class II recall: Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufac…
August 19, 2026·High
- Apollo Care, LLC — Class II recall: SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Sub…
August 19, 2026·High
- Apollo Care, LLC — Class II recall: SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcut…
August 19, 2026·High
- Prestige Brands Holdings — Class II recall: CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Steri…
August 19, 2026·High
- Shoolin Pharma Chem LLP — Class II recall: TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compound…
August 19, 2026·High
- Shoolin Pharma Chem LLP — Class II recall: SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Co…
August 19, 2026·High
- Shoolin Pharma Chem LLP — Class II recall: TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compoundin…
August 19, 2026·High
- Apollo Care, LLC — Class II recall: SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial,…
August 19, 2026·High
- Shoolin Pharma Chem LLP — Class II recall: TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding…
August 19, 2026·High
- Shoolin Pharma Chem LLP — Class II recall: SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription C…
August 19, 2026·High
- Victory Medical Center Pharmacy — Class I recall: Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, A…
August 19, 2026·Critical
- Apollo Care, LLC — Class II recall: SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Sub…
August 19, 2026·High
- Heritage Pharmaceuticals Inc — Class II recall: CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only,…
August 19, 2026·High
- Apollo Care, LLC — Class II recall: SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcut…
August 19, 2026·High
- Liebel-Flarsheim Company LLC — Class I recall: Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically…
August 19, 2026·Critical
- Apollo Care, LLC — Class II recall: SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial,…
August 19, 2026·High
- Apollo Care, LLC — Class II recall: SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial,…
August 19, 2026·High
- Sunny Pharmtech Inc. — Class I recall: Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only,…
August 12, 2026·Critical
- Aurobindo Pharma USA Inc — Class II recall: Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distribut…
August 12, 2026·High
- Sunny Pharmtech Inc. — Class I recall: Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only,…
August 12, 2026·Critical
- Central Admixture Pharmacy Services Inc — Class III recall: Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient speci…
August 12, 2026·Medium
- Zydus Pharmaceuticals (USA) Inc — Class II recall: Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactur…
August 12, 2026·High
- Glenmark Pharmaceuticals Inc., USA — Class II recall: Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed…
August 5, 2026·High
- MYLAN PHARMACEUTICALS INC — Class II recall: Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials…
August 5, 2026·High
- MICRO LABS USA INC — Class II recall: Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bo…
August 5, 2026·High
Other enforcement types
Sourced from openFDA public enforcement data. Not legal or regulatory advice. Report an error via /contact.