Browse Drug Recalls

3,458 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,458 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 3,458 FDA drug recalls.

Clear
DateProductReasonClassFirm
Mar 15, 2021 Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budeso... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 SYMPROIC (NAIDEMEDINE) TABLETS 0.2MG 30 TABLETS; NDC 59385-041-30; RX; TABLETS CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 TRAMADOL HYDROCHLORIDE TABLETS USP 100MG, 100-count bottle, Rx Only, Manufact... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Folivane-Plus with Ascorbic Acid Precursors Iron/Folic Acid/Vitamin Supplemen... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Nature's Truth Absorbable Calcium 1200 mg plus D3 5000 IU 120 Softgels Dietar... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 CIPRODEX (CIPROFLOXACIN 0.3 AND DEXAMETHASONE 0.1%) 7.5ML; NDC/UPC 0078-0799... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) ... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tabl... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
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 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 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
Jan 25, 2021 Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets pe... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... Class II Nostrum Laboratories Inc
Jan 22, 2021 Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx O... CGMP Deviations: Individual Unidentified impurities results of the product was found at higher si... Class II Ascend Laboratories LLC
Jan 22, 2021 Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx On... CGMP Deviations: Individual Unidentified impurities results of the product was found at higher si... Class II Ascend Laboratories LLC
Jan 8, 2021 Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmac... CGMP deviations. Class II Taro Pharmaceuticals U.S.A., Inc.
Jan 4, 2021 Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets pe... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... Class II Nostrum Laboratories Inc
Jan 1, 2021 Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit ... cGMP deviations: The firm was notified of the manufacturer's expanded recall. Class II Precision Dose Inc.
Dec 28, 2020 Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only... cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia... Class II Sunstar Americas, Inc.
Dec 23, 2020 IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 1.7 fl. oz. (50 ml) bottl... CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled... Class II Shane Erickson Inc
Dec 23, 2020 IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Mad... CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled... Class II Shane Erickson Inc
Dec 23, 2020 IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 10.1 fl. oz. (300 ml), Ma... CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled... Class II Shane Erickson 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.