Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Feb 20, 2024 Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile inje... Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delaminat... Class II Denver Solutions, LLC DBA Leiters Health
Feb 20, 2024 Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial,... Failed Impurities/Degradation Specifications: Out of specification for organic impurities Class II Eugia US LLC
Feb 20, 2024 Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Dis... Failed Impurities/Degradation Specifications: Out of specification for organic impurities Class II Eugia US LLC
Feb 20, 2024 Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL... Failed Dissolution Specifications Class II Eugia US LLC
Feb 20, 2024 Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Sing... Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delaminat... Class II Denver Solutions, LLC DBA Leiters Health
Feb 20, 2024 Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Comp... Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delaminat... Class II Denver Solutions, LLC DBA Leiters Health
Feb 19, 2024 PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antis... CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing ... Class II Seatex LLC
Feb 19, 2024 PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Clean... CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing ... Class II Seatex LLC
Feb 19, 2024 7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scen... CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing ... Class II Seatex LLC
Feb 19, 2024 PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Clean... CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing ... Class II Seatex LLC
Feb 19, 2024 7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic,... CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing ... Class II Seatex LLC
Feb 16, 2024 Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine H... Stability testing failures for one or two of the four active pharmaceutical ingredients among the... Class II Global Corporation
Feb 16, 2024 Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine ma... Stability testing failures for one or two of the four active pharmaceutical ingredients among the... Class II Global Corporation
Feb 14, 2024 Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays,... CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex Class II Golden State Medical Supply Inc.
Feb 13, 2024 Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottl... Failed Impurities/Degradation Specifications: Out-of-specification test results. Class II Amneal Pharmaceuticals of New York, LLC
Feb 12, 2024 CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1... CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was... Class II MCKESSON CORPORATION
Feb 12, 2024 Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs... CGMP Deviations: Out of specification for residual solvents. Class II Micro Labs Limited
Feb 9, 2024 HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 bli... an out of specification result obtained during routine stability testing for Impurities. There i... Class II The Harvard Drug Group LLC dba Major Pharmaceut...
Feb 9, 2024 Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net ... CGMP Deviations: potential presence of Burkholderia cepacia complex Class II Apotex Corp.
Feb 9, 2024 Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured b... Failed Stability Specifications: Out of specification for blend uniformity. Class II Micro Labs Limited
Feb 7, 2024 Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MF... cGMP Deviations: Products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Feb 7, 2024 Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Sy... cGMP Deviations: Products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Feb 7, 2024 Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vi... cGMP Deviations: Products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Feb 6, 2024 Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only... cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Af... Class II Mallinckrodt Hospital Products Inc.
Feb 6, 2024 Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP uni... cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Af... Class II Mallinckrodt Hospital Products Inc.
Feb 5, 2024 Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when rec... Labeling: Incorrect or Missing Package Insert Class II Lupin Pharmaceuticals Inc.
Feb 5, 2024 Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bo... Failed Dissolution Specifications: Out of specification for dissolution. Class II SUN PHARMACEUTICAL INDUSTRIES INC
Feb 2, 2024 Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This pac... Subpotent Drug: Out of specification for assay Class II Bausch Health Companies, Inc.
Feb 1, 2024 Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactur... CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on ... Class II NATCO Pharma Limited
Jan 30, 2024 Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Package... Lack of Assurance of Sterility Class II Brassica Pharma Pvt Ltd
Jan 30, 2024 Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%... Lack of Assurance of Sterility Class II Brassica Pharma Pvt Ltd
Jan 30, 2024 CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrol... Lack of Assurance of Sterility Class II Brassica Pharma Pvt Ltd
Jan 30, 2024 Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Pa... Lack of Assurance of Sterility Class II Brassica Pharma Pvt Ltd
Jan 25, 2024 Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distribut... CGMP Deviations Class II Amerisource Health Services LLC
Jan 25, 2024 Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent Internat... CGMP Deviations Class II Alpha Aromatics
Jan 23, 2024 Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL),... Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified ... Class II Baxter Healthcare Corporation
Jan 22, 2024 Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injectio... Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyon... Class II IntegraDose Compounding Services LLC
Jan 19, 2024 Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 dro... CGMP Deviations: Potential Glass and Silicone particulates in product Class II Bestco LLC
Jan 19, 2024 Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 dro... CGMP Deviations: Potential Glass and Silicone particulates in product Class II Bestco LLC
Jan 19, 2024 Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 d... CGMP Deviations: Potential Glass and Silicone particulates in product Class II Bestco LLC
Jan 19, 2024 CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160... CGMP Deviations: Potential Glass and Silicone particulates in product Class II Bestco LLC
Jan 19, 2024 Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials CGMP Deviations Class II OMEZA LLC
Jan 19, 2024 Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS CGMP Deviations Class II OMEZA LLC
Jan 19, 2024 Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic,... CGMP Deviations: Potential Glass and Silicone particulates in product Class II Bestco LLC
Jan 18, 2024 Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun ... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hou... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun ... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distr... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablet... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES 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.