Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 15, 2021 | Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg sema... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Ilevro (nepafenac ophthalmic suspension) 0.3% 3 mL Sterile Rx Only NDC 0065-1... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | LORATADINE 10MG 100 ND 24H; NDC/UPC 345802650788; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Vraylar (cariprazine) capsules in all pack sizes, styles and strengths Rx onl... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | EPINEPHRINE INJECTION USP, 0.15 MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES ... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | LEVOXYL Tablets, USD, 150MCG, 100-count bottle, Rx Only, Distributed by Pfize... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles Rx Only NDC ... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Epinephrine Injection, USP Auto-Injectors in all strengths, packs and styles ... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | ATROVENT HFA 17MCG 12.9GM; NDC/UPC 597008717; RX; INHALER MEDICAL INTERNAL - ... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | MURO-128 2% 15ML OPTH; NDC/UPC 324208276150; OTC; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Wee... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly) Delivers 0.1 mg/d... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant. T... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Nuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | EPINEPHRINE INJECTION USP, 0.3MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (A... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Cetirizine Hydrochloride Tablets, 10 mg, 300 Count; NDC/UPC 345802919878; OTC... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | VIMPAT (lacosamide) Tablets, 200mg, 60-count bottle, Rx Only, Manufactured f... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Livalo (pitavastatin) tablets 2 mg* Rx Only NdC 66869-204-90 Manufactured und... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Acne Medication Benzoyl Peroxide Gel USP, 5% Net Wt 1.5 oz (42.5 g) NDC 0536-... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With D... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP,150MG 100-count bottles, Rx Only, Man... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 Tablets Rx Only ND... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | COREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bo... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Namzaric (memantine HCl extended release and donepezil HCl) capsules 14 mg/10... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | TRAZODONE HYDROCHLORIDE TABLETS, USP 50MG 100 TABLET 10X10UD; NDC/UPC 0904-68... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | CARBIDOPA AND LEVORDOPA TABLETS, USP 25MG/100MG 100 TABLETS; NDC/UPC 51862-8... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | INTEGRA 325/40/3mg 90-count bottle, NDC: 52747-710-60 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containi... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL contains 6 mg ose... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL (1 2/3 fl oz) Manufactru... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN ... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | NIACIN 250MG 110; NDC/UPC 740985228494; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Linzess (linaclotide) capsules 72 mcg/capsule 30 capsules Rx Only NDC 0456-12... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAP... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Iron 100 with Vitamin C Tablets Dietary Supplement 100 Tablets NDC 60258-099-... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Calcium Acetate Capsules 667 mg 200 Capsules Rx only NDC 23155-531-02 Manufac... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan H... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | ADVAIR HFA 45-21MCG 12GM; NDC/UPC 173071520; RX; INHALER MEDICAL INTERNAL - M... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | FaBB Vitamin B6 (as Pyridoxine Hydrochloride) 25 mg Folic Acid 2.2 mg Vitamin... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Darifenacin Extended-release Tablets 7.5 mg 30 Tablets Rx only Manufactured b... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | VITAMIN D3 50MCG 100 CALC; NDC/UPC 880681170007; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 1 A Day Nutrit... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | LYRICA (pregabalin) capsules, 200mg 90-count bottle, Rx Only, Distributed by:... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
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.