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
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
Dec 14, 2020 Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use On... cGMP deviations: Vials may not be sealed correctly affecting sterility. Class II CIPLA
Dec 9, 2020 Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufac... CGMP Deviations Class II Akebia Therapeutics dba Keryx Biopharmaceutials...
Dec 8, 2020 Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use O... CGMP Deviations Class II Shilpa Medicare Limited
Dec 8, 2020 Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: ... CGMP Deviations Class II Shilpa Medicare Limited
Dec 8, 2020 Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use O... CGMP Deviations Class II Shilpa Medicare Limited
Dec 8, 2020 Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only,... CGMP Deviations Class II Shilpa Medicare Limited
Dec 8, 2020 Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must... CGMP Deviations Class II Shilpa Medicare Limited
Dec 8, 2020 Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: ... CGMP Deviations Class II Shilpa Medicare Limited
Dec 1, 2020 Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Mad... cGMP deviations: Product made at the same facility where product tested was sub-potent. Class II GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALI...
Dec 1, 2020 Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. ... cGMP deviations: Product made at the same facility where product tested was sub-potent. Class II GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALI...
Nov 20, 2020 HUMAN CHORIONIC GONADOTROPIN 1,250 IU per vial Aso contains Mannitol 9%, Sodi... CGMP deviations: Lack of potency testing. Class II Complete Pharmacy and Medical Solutions, LLC.
Nov 20, 2020 HUMAN CHORIONIC GONADOTROPIN 11,000 IU per vial Aso contains Mannitol 9%, Sod... CGMP deviations: Lack of potency testing. Class II Complete Pharmacy and Medical Solutions, LLC.
Nov 20, 2020 HUMAN CHORIONIC GONADOTROPIN 6,000 IU per vial Aso contains Mannitol 9%, Sodi... CGMP deviations: Lack of potency testing. Class II Complete Pharmacy and Medical Solutions, LLC.
Nov 20, 2020 HUMAN CHORIONIC GONADOTROPIN 5,000 IU per vial Aso contains Mannitol 9%, Sodi... CGMP deviations: Lack of potency testing. Class II Complete Pharmacy and Medical Solutions, LLC.

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.