Browse Drug Recalls

557 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 557 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 557 FDA drug recalls in 2024.

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DateProductReasonClassFirm
Mar 1, 2024 S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging... Failed Stability Specifications Class II Specialty Process Labs LLC
Feb 29, 2024 hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bot... Lack of Assurance of Sterility Class II Optikem International, Inc.
Feb 29, 2024 TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manuf... Lack of Assurance of Sterility Class II Optikem International, Inc.
Feb 29, 2024 FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 m... Lack of Assurance of Sterility: Firm did not perform process validation. Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Feb 29, 2024 TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ ... Lack of Assurance of Sterility Class II Optikem International, Inc.
Feb 29, 2024 TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufacture... Lack of Assurance of Sterility Class II Optikem International, Inc.
Feb 29, 2024 TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), ... Lack of Assurance of Sterility Class II Optikem International, Inc.
Feb 29, 2024 TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (... Lack of Assurance of Sterility Class II Optikem International, Inc.
Feb 29, 2024 TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Ma... Lack of Assurance of Sterility Class II Optikem International, Inc.
Feb 29, 2024 TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ... Lack of Assurance of Sterility Class II Optikem International, Inc.
Feb 29, 2024 TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL ... Lack of Assurance of Sterility Class II Optikem International, Inc.
Feb 29, 2024 TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manu... Lack of Assurance of Sterility Class II Optikem International, Inc.
Feb 29, 2024 Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenou... Lack of Assurance of Sterility: Firm did not perform process validation. Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Feb 22, 2024 Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, ... Failed Stability Specification: Water determination was found not complying with specification. Class II Eugia US LLC
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 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 Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured fo... Defective Container: Out of specification for weight due to a slow leakage at the 12-month stabil... Class III Contract Pharmaceuticals Limited Canada
Feb 20, 2024 Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL... Failed Dissolution Specifications Class II Eugia US LLC
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 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 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 Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured... Defective Container: Out of specification for weight due to a slow leakage at the 12-month stabil... Class III Contract Pharmaceuticals Limited Canada
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 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 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 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 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 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 15, 2024 Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial ... Presence of Particulate Matter Class I Eugia US LLC
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 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 12, 2024 ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-c... Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ing... Class I FA Online Inc
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 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 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 Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076... Failed Dissolution Specifications: results slightly under spec at at 9-months. Class III Stason Pharmaceuticals, Inc.
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 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 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 6, 2024 Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distribut... Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undecla... Class I Today The World
Feb 6, 2024 SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distrib... Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... Class I Today The World
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 6, 2024 Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed... Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... Class I Today The World
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 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 Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, D... Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved ... Class I Super Chill Products
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

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.