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.

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DateProductReasonClassFirm
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.