Browse Drug Recalls
633 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 633 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 633 FDA drug recalls in 2026.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 6, 2026 | Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-coun... | Subpotent Drug | Class II | ACCORD HEALTHCARE, INC. |
| Aug 6, 2026 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx ... | Subpotent Drug | Class II | ACCORD HEALTHCARE, INC. |
| Aug 6, 2026 | Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx... | Subpotent Drug | Class II | ACCORD HEALTHCARE, INC. |
| Aug 6, 2026 | Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx O... | Subpotent Drug | Class II | ACCORD HEALTHCARE, INC. |
| Aug 6, 2026 | Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count ... | Subpotent Drug | Class II | ACCORD HEALTHCARE, INC. |
| Aug 5, 2026 | Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glut... | Microbial Contamination of Sterile Products - out of specifications results were obtained for bac... | Class I | OPTIMAL BALANCE PHARMACY |
| 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 | Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefille... | Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of ... | Class I | Fresenius Kabi USA, LLC |
| 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 | Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured ... | CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Aug 3, 2026 | Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for:... | Failed content uniformity specifications. | Class II | Lupin Pharmaceuticals Inc. |
| 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 31, 2026 | Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organical... | Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless st... | Class I | Liebel-Flarsheim Company LLC |
| 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 | Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majest... | Failed stability specifications | Class II | BioSpectra, Inc. |
| Jul 29, 2026 | PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial,... | Discolored solution. The firm has received market complaints reporting green to dark green discol... | Class II | Shilpa Medicare Limited |
| Jul 29, 2026 | PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose via... | Discolored solution. The firm has received market complaints reporting green to dark green discol... | Class II | Shilpa Medicare Limited |
| 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 28, 2026 | Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous ... | Lack of Assurance of Sterility | Class II | Regeneron Pharmaceuticals Inc |
| Jul 24, 2026 | Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose ... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Inf... | Presence of Particulate Matter | Class I | Baxter Healthcare Corporation |
| Jul 24, 2026 | Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged i... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, p... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 m... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx... | Failed Dissolution Specifications | Class II | Mylan Pharmaceuticals Inc |
| Jul 24, 2026 | Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL via... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packa... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT F... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Sing... | Presence of Particulate Matter: Product contaminated with particulate matter identified as glass ... | Class I | American Regent, Inc. |
| Jul 24, 2026 | ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT F... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| Jul 24, 2026 | Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC U... | Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, ... | Class II | American Regent, Inc. |
| 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 |
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.