Browse Drug Recalls

1,152 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,152 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 1,152 FDA drug recalls in 2021.

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DateProductReasonClassFirm
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 11, 2021 ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMAC... Defective Delivery System: customer complaints concerning the injector pen breaking apart and dis... Class II Ferring Pharmaceuticals Inc
Mar 11, 2021 ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACT... Defective Delivery System: customer complaints concerning the injector pen breaking apart and dis... Class II Ferring Pharmaceuticals Inc
Mar 11, 2021 Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only,... Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown i... Class II Breckenridge Pharmaceutical, Inc
Mar 11, 2021 Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial pac... Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may res... Class II Sagent Pharmaceuticals Inc
Mar 10, 2021 Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes... Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of th... Class I Sanit Technologies, LLC dba Durisan
Mar 10, 2021 heal the world, moisturizing original hand sanitizer, Non-Sterile Solution, A... Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking wate... Class I PNHC, LLC.
Mar 10, 2021 CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER, pack... CGMP deviations: Product being recalled as it was made in the same facility where contamination w... Class II China Gel Inc
Mar 10, 2021 Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, liste... CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the sa... Class II Sanit Technologies, LLC dba Durisan
Mar 10, 2021 CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER, packaged as... CGMP deviations: Product being recalled as it was made in the same facility where contamination w... Class II China Gel Inc
Mar 10, 2021 aulief (Organic Camphor 3.00% Organic Menthol 5.00%), topical pain relief, pa... CGMP deviations: Product being recalled as it was made in the same facility where contamination w... Class II China Gel Inc
Mar 10, 2021 Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes... CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the sa... Class II Sanit Technologies, LLC dba Durisan
Mar 10, 2021 Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, liste... Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of th... Class I Sanit Technologies, LLC dba Durisan
Mar 9, 2021 Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe ... Temperature Abuse Class III Cardinal Health Inc.
Mar 9, 2021 0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manu... Presence of particulate matter.one confirmed customer report of particulate matter within two se... Class II ICU Medical Inc
Mar 8, 2021 Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose... Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed ... Class II Akorn, Inc.
Mar 4, 2021 Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Phar... Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities... Class III Teva Pharmaceuticals USA
Mar 2, 2021 Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottle... Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 co... Class I A-S Medication Solutions LLC.
Mar 2, 2021 Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Pac... cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently tak... Class II Direct Rx
Mar 2, 2021 Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vial... Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP Class III Ferring Pharmaceuticals Inc
Feb 26, 2021 Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Di... Failed Dissolution Specifications: Out-of-specification results observed for dissolution during s... Class II Dr. Reddy's Laboratories, Inc.
Feb 26, 2021 Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each contain... Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low) Class II Alvogen, Inc
Feb 22, 2021 Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouche... Subpotent Class III SUN PHARMACEUTICAL INDUSTRIES INC
Feb 19, 2021 Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx... Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosi... Class III Jubilant Cadista Pharmaceuticals, Inc.
Feb 19, 2021 Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 5511... Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and... Class III Dr. Reddy's Laboratories, Inc.
Feb 19, 2021 Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.... Defective Delivery System: Out of specification for mechanical peel. Class II Noven Pharmaceuticals Inc
Feb 19, 2021 Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1... Defective Delivery System: Out of specification for mechanical peel. Class II Noven Pharmaceuticals Inc
Feb 19, 2021 Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1... Defective Delivery System: Out of specification for mechanical peel. Class II Noven Pharmaceuticals Inc
Feb 19, 2021 Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.... Defective Delivery System: Out of specification for mechanical peel. Class II Noven Pharmaceuticals Inc
Feb 18, 2021 Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For I... Crystallization: customer complaints for crystallization in finished product. Class I Zydus Pharmaceuticals (USA) 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.