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Browse Drug Recalls

1,392 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,392 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 1,392 FDA drug recalls in 2022.

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DateProductReasonClassFirm
Apr 22, 2022 Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23... CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. Class II Pfizer Inc.
Apr 22, 2022 Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23... CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. Class II Pfizer Inc.
Apr 22, 2022 Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 ... CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits. Class II Pfizer Inc.
Apr 21, 2022 TORCO RACING FUELS HAND SANITIZER, Alcohol Antiseptic 80% Topical Solution, H... CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specificatio... Class II Torco Race Fuels
Apr 21, 2022 Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expresse... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Apr 21, 2022 Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Dist... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Apr 21, 2022 Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufac... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Apr 21, 2022 Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by:... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Apr 21, 2022 Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx ... CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Te... Class II McKesson Corporation dba McKesson Drug Company
Apr 15, 2022 Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC... cGMP Deviations Class II Teva Pharmaceuticals USA Inc
Apr 15, 2022 Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Apr 15, 2022 Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs o... Failed Dissolution Specifications Class II Dr. Reddy's Laboratories, Inc.
Apr 15, 2022 Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-co... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Apr 15, 2022 Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded m... Subpotent drug Class I Valor Compounding Pharmacy, Inc DBA Valor Comp...
Apr 15, 2022 Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per b... Failed viscosity specification - product was below specificcation Class III Akorn, Inc.
Apr 15, 2022 Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-c... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Apr 15, 2022 Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Apr 15, 2022 Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded m... Subpotent drug Class I Valor Compounding Pharmacy, Inc DBA Valor Comp...
Apr 15, 2022 Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Apr 15, 2022 Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Apr 14, 2022 Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Man... Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content Class III Monarch PCM, LLC
Apr 13, 2022 Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL... cGMP deviations: Temperature abuse Class III Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Kinevac (Sincalide for Injection), 5mcg per vial, 10 vials per box, Rx only, ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Transderm Scop (scopolamine) Transdermanl System, 1 mg/ 3 days, 10 (patches) ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Intralipid (I.V. Fat emulsion), 20%, 100 mL bag, Rx only, MFG: Baxter Healthc... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL)... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Ondansetron HCL, Tab 8 mg filmcoated, 30-count bottle, Rx only, MFG: Sandoz P... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Propofol Injectable Emulsion, USP 200 mg per 20 mL (10 mg per mL), twenty-fiv... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Ciprofloxacin Ophthalmic Solution 0.3%, 5 mL bottle, Rx only, MFG: Sandoz Pha... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Meclizine Hydrochloride Tablets, USP, 25 mg, 50-count cartons (5 x10 unit dos... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottle, Rx only, MFG:... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Metronidazole Vaginal Gel USP, 0.75% with 5 applicators, Net Wt. 70 g tube, R... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 MethyLPREDNISolone Acetate Injectable Suspension, USP, 200 mg/5 mL (40 mg/mL)... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Bupivacaine HCl Injection, Single Dose Vial, 0.75%, 10 mL/7.5 mg/mL, Rx only,... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Firmagon (degarelix for injection) 240 mg, Starting Dose, packaged in a kit, ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Lidocaine and Prilocaine Cream, 2.5%/2.5%, 5 gram tubes, Rx only, MFG: Sandoz... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle, MFG: ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 40 mg/mL,... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 MethyLPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 MIOSTAT (Carbachol Intraocular Solution, USP) 0.01%, 1.5 mL, Rx only, MFG: Al... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Albuterol Sulfate Inhalation Solution, 0.021%, 0.63 mg/3mL, packaged in 30 x ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Glucagen (glucagon) for injection, packaged in a 10-count box, (10 vials each... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Propofol Injectable Emulsion, USP, 200 mg/ 20 mL (10 mg/mL), packaged in a) ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Diprivan (Propofol) Emulsion, 100 mg/mL, 10mL vial, Rx only, MFG: App Pharma... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Lidocaine Patch, 5%, 30-count box, Rx only, Manufacturer: Rhodes Pharmaceutic... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Xylocaine - MPF (lidocaine HCl and epinephrine injection, USP), 1%, 300 mg/30... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Adrenalin (epinephrine injection, USP) 30 mg/30 mL (1mg/mL), 30 mL multiple d... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Sumatriptan Injection, USP, 6mg/0.5 mL, packaged in a box of 5 x 0.5 mL singl... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 25 X 3m... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office

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.