Browse Drug Recalls
14,449 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,449 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 14,449 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 5, 2026 | Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufac... | CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. | Class II | Zydus Pharmaceuticals (USA) Inc |
| Aug 4, 2026 | Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manu... | Failed Dissolution Specifications | Class II | Novartis Pharmaceuticals Corporation |
| Aug 3, 2026 | TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compoundi... | CGMP Deviations:Noted during FDA inspection | Class II | Shoolin Pharma Chem LLP |
| Aug 3, 2026 | SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription... | CGMP Deviations:Noted during FDA inspection | Class II | Shoolin Pharma Chem LLP |
| Aug 3, 2026 | TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compo... | CGMP Deviations:Noted during FDA inspection | Class II | Shoolin Pharma Chem LLP |
| Aug 3, 2026 | TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compoun... | CGMP Deviations:Noted during FDA inspection | Class II | Shoolin Pharma Chem LLP |
| Aug 3, 2026 | SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescriptio... | CGMP Deviations:Noted during FDA inspection | Class II | Shoolin Pharma Chem LLP |
| Jul 30, 2026 | CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx On... | Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles. | Class II | Heritage Pharmaceuticals Inc |
| Jul 29, 2026 | SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Via... | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II | Apollo Care, LLC |
| Jul 29, 2026 | SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Sub... | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II | Apollo Care, LLC |
| Jul 29, 2026 | SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcu... | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II | Apollo Care, LLC |
| Jul 29, 2026 | SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vi... | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II | Apollo Care, LLC |
| Jul 29, 2026 | SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vi... | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II | Apollo Care, LLC |
| Jul 29, 2026 | CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, St... | Lack of assurance of sterility. The recall is due to potential contamination | Class II | Prestige Brands Holdings |
| Jul 29, 2026 | SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Sub... | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II | Apollo Care, LLC |
| Jul 29, 2026 | SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For ... | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II | Apollo Care, LLC |
| Jul 29, 2026 | SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Do... | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II | Apollo Care, LLC |
| Jul 29, 2026 | SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For ... | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II | Apollo Care, LLC |
| Jul 29, 2026 | SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Sub... | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II | Apollo Care, LLC |
| Jul 29, 2026 | SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dos... | Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material | Class II | Apollo Care, LLC |
| Jul 23, 2026 | Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distri... | shortfill; reports of empty capsules. | Class II | Aurobindo Pharma USA Inc |
| Jul 23, 2026 | Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distribu... | CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jul 22, 2026 | Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL -... | Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops. | Class II | MICRO LABS USA INC |
| Jul 16, 2026 | Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill... | Presence of Particulate Matter: Hair was found in product | Class II | Fresenius Kabi USA, LLC |
| Jul 16, 2026 | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL)... | Presence of Particulate Matter: Hair was found in products | Class II | Fresenius Kabi USA, LLC |
| Jul 16, 2026 | Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single D... | Presence of Particulate Matter: Hair was found in products | Class II | Fresenius Kabi USA, LLC |
| Jul 16, 2026 | Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL)... | Presence of Particulate Matter: Hair was found in products | Class II | Fresenius Kabi USA, LLC |
| Jul 16, 2026 | Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5... | Presence of Particulate Matter: Hair was found in products | Class II | Fresenius Kabi USA, LLC |
| Jul 14, 2026 | Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precisi... | Failed Impurities/Degradation Specifications | Class II | Precision Dose Inc. |
| Jul 14, 2026 | Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Ster... | Lack of Assurance of Sterility | Class II | Rohto-Mentholatum (Vietnam) Co., Ltd. |
| Jul 14, 2026 | Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0... | Lack of Assurance of Sterility | Class II | Rohto-Mentholatum (Vietnam) Co., Ltd. |
| Jul 14, 2026 | Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone... | Lack of Assurance of Sterility | Class II | Rohto-Mentholatum (Vietnam) Co., Ltd. |
| Jul 14, 2026 | Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polyso... | Lack of Assurance of Sterility | Class II | Rohto-Mentholatum (Vietnam) Co., Ltd. |
| Jul 14, 2026 | Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Ster... | Lack of Assurance of Sterility | Class II | Rohto-Mentholatum (Vietnam) Co., Ltd. |
| Jul 14, 2026 | Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.... | Lack of Assurance of Sterility | Class II | Rohto-Mentholatum (Vietnam) Co., Ltd. |
| Jul 14, 2026 | Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polyso... | Lack of Assurance of Sterility | Class II | Rohto-Mentholatum (Vietnam) Co., Ltd. |
| Jul 14, 2026 | Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polyso... | Lack of Assurance of Sterility | Class II | Rohto-Mentholatum (Vietnam) Co., Ltd. |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 100 Tablets (10 x 10 ... | Subpotent Drug | Class II | Major Pharmaceuticals |
| Jul 13, 2026 | Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx o... | Presence of Precipitate: medication was crystallizing and particles floating in the bottle | Class II | Rising Pharma Holding, Inc. |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) uni... | Subpotent Drug | Class II | Major Pharmaceuticals |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 ... | Subpotent Drug | Class II | Major Pharmaceuticals |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 ... | Subpotent Drug | Class II | Major Pharmaceuticals |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) uni... | Subpotent Drug | Class II | Major Pharmaceuticals |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 un... | Subpotent Drug | Class II | Major Pharmaceuticals |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 un... | Subpotent Drug | Class II | Major Pharmaceuticals |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) u... | Subpotent Drug | Class II | Major Pharmaceuticals |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 un... | Subpotent Drug | Class II | Major Pharmaceuticals |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 un... | Subpotent Drug | Class II | Major Pharmaceuticals |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) u... | Subpotent Drug | Class II | Major Pharmaceuticals |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) uni... | Subpotent Drug | Class II | Major Pharmaceuticals |
Frequently Asked Questions
When a drug safety issue is identified, through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks, the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.