Browse Drug Recalls
3,394 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,394 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 3,394 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 16, 2021 | Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottl... | cGMP deviations: Discolored acetaminophen | Class II | Spirit Pharmaceuticals |
| Jun 10, 2021 | Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured... | CGMP Deviations | Class II | CIPLA |
| Jun 9, 2021 | Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pf... | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... | Class II | Pfizer Inc. |
| Jun 9, 2021 | Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfiz... | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acc... | Class II | Pfizer Inc. |
| Jun 9, 2021 | Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets... | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acc... | Class II | Pfizer Inc. |
| Jun 1, 2021 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx... | CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da... | Class II | VIONA PHARMACEUTICALS INC |
| May 12, 2021 | MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70... | CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufa... | Class II | Global Sanitizers LLC |
| May 12, 2021 | MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70... | CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufa... | Class II | Global Sanitizers LLC |
| May 12, 2021 | MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70... | CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufa... | Class II | Global Sanitizers LLC |
| May 12, 2021 | MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alco... | CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufac... | Class II | Global Sanitizers LLC |
| May 11, 2021 | ProtectoRx (ethyl alcohol 70%), packaged in a) 2 FL OZ (59 mL), NDC 75408-002... | CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufacture... | Class II | DIBAR NUTRICIONAL S DE RL DE CV |
| May 11, 2021 | ADVANCE HAND SANITIZER, (ethyl alcohol 70%), 16 FL OZ (473.2 mL), Imported by... | CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufacture... | Class II | DIBAR NUTRICIONAL S DE RL DE CV |
| May 11, 2021 | DiBAR LABS Hand Sanitizer, (ethyl alcohol 70%), packaged as a) 16 FL OZ (473.... | CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufacture... | Class II | DIBAR NUTRICIONAL S DE RL DE CV |
| Apr 15, 2021 | Oxygen, Compressed, USP UN 1072, packaged in cylinders labeled as: a) M6 Medi... | cGMP deviations | Class II | Grace Healthcare Medical, Inc |
| Mar 29, 2021 | foamyiQ Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1%), Net Conten... | CGMP Deviations | Class II | Spartan Chemical Co Inc |
| Mar 29, 2021 | Lite'n Foamy E2 Sanitizing Handwash (Benzalkonium Chloride, 0.13%), Net Conte... | CGMP Deviations | Class II | Spartan Chemical Co Inc |
| Mar 29, 2021 | Lite'n Foamy Healthcare Personnel Handwash (Chloroxylenol, 1.0%), Net Content... | CGMP Deviations | Class II | Spartan Chemical Co Inc |
| Mar 29, 2021 | Antiseptic Hand Cleaner (Chloroxylenol, 1.0%), Net Contents: 1 US Gallon/ 3.7... | CGMP Deviations | Class II | Spartan Chemical Co Inc |
| Mar 29, 2021 | Lite'n Foamy Eucalyptus Mint Sanitizing Handwash (Benzalkonium Chloride, 0.13... | CGMP Deviations | Class II | Spartan Chemical Co Inc |
| Mar 25, 2021 | Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-... | CGMP Deviaitons | Class II | Cosette Pharmaceuticals, Inc. |
| Mar 19, 2021 | ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... | CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Rel... | Class II | CareFusion 213, LLC |
| Mar 19, 2021 | ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropy... | CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Rel... | Class II | CareFusion 213, LLC |
| 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 | 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 | 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 | 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 | 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 | 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 | Ivermectin Tablets USP 3 mg 20 Tablets (2 Foil Strips of 10 tablets each) Rx ... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | ERYTHROMYCIN TABLETS, USP 250MG 30; NDC/UPC 69238-1484-3; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topi... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Vaniqa (eflornithine hydrochloride) Cream, 13.9% For Topical Use Only Net wt.... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | MICONAZOLE 7 2% 45GM APL; NDC/UPC 009047734459; OTC; CREAM | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Triamcinolone Acetonide Ointment, USP, 0.025% 80g; Rx Only, Distributed by: P... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NO... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets ... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | medroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Onl... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | CATAPRES-TTS-2 1X4; NDC/UPC 597003234; RX; ADHESIVE PATCHES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | ONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | UBRELVY 100MG 10UD CPLT; NDC/UPC 23650110; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Intrarosa Prasterone Vaginal Inserts 6.5 mg 28 inserts/applicators Rx Only Ma... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Medroxyprogesterone acetate injectable suspension, USP 150 mg per mL 1 mL Pre... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Eletriptan Hydrobromide Tablets 20 mg* 6(1x6) Unit-dose Tablets Rx only NDC 5... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | PREGABALIN CAPSULES 300MG 90 ; NDC 43598-298-90; RX; CAPSULES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | LEUCOVORIN 15MG 24; NDC/UPC 54449810; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only, Manufactured ... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Synjardy (empagliflozin and metformin hydrochloride) Tablets 12.5 mg/1000 mg ... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg... | 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.