Browse Drug Recalls

2,002 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,002 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 2,002 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Mar 3, 2026	Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx ...	Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-...	Class II	Rising Pharma Holding, Inc.
Feb 12, 2026	Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1...	Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 ...	Class III	Slate Run Pharmaceuticals
Jan 15, 2026	methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton cont...	Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blis...	Class II	Greenstone Llc
Dec 26, 2025	parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net ...	Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and ex...	Class III	Haleon US Holdings LLC
Dec 16, 2025	Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx o...	Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.	Class II	SpecGx, LLC
Nov 26, 2025	Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, F...	Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle ...	Class III	Winder Laboratories, LLC
Nov 7, 2025	Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dos...	Defective Container - A defect in the side-seal which allows leakage of product.	Class III	Teva Pharmaceuticals USA, Inc
Oct 29, 2025	POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly con...	Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the produc...	Class I	Otsuka ICU Medical LLC
Oct 29, 2025	POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly co...	Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the produc...	Class I	Otsuka ICU Medical LLC
Oct 17, 2025	Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet f...	Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly state...	Class II	Aero Healthcare
Oct 10, 2025	Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile,...	Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.	Class II	Safecor Health, LLC
Oct 9, 2025	FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 5...	Labeling: Incorrect or Missing Lot and/or Exp Date	Class III	STAQ Pharma, Inc.
Oct 9, 2025	Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50...	Labeling: Incorrect or Missing Lot and/or Exp Date	Class III	STAQ Pharma, Inc.
Oct 9, 2025	Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syri...	Labeling: Incorrect or Missing Lot and/or Exp Date	Class III	STAQ Pharma, Inc.
Oct 7, 2025	Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottl...	Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, ...	Class II	Rising Pharma Holding, Inc.
Oct 1, 2025	Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dos...	Presence of Particulate Matter: Particulate matter identified as glass	Class II	Aspiro Pharma Limited
Oct 1, 2025	ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distribu...	Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to ind...	Class II	Church & Dwight Co., Inc.
Sep 12, 2025	Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl P...	Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was...	Class II	Private Label Skin Care Inc.
Sep 12, 2025	Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7...	Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was...	Class II	Private Label Skin Care Inc.
Sep 12, 2025	Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 ...	Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was...	Class II	Private Label Skin Care Inc.
Sep 12, 2025	mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Sk...	Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was...	Class II	Private Label Skin Care Inc.
Sep 12, 2025	Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604	Labeling: Not Elsewhere Classified	Class III	Letco Medical LLC
Sep 12, 2025	ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverl...	Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was...	Class II	Private Label Skin Care Inc.
Sep 12, 2025	edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) ...	Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was...	Class II	Private Label Skin Care Inc.
Aug 27, 2025	Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, ...	Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were...	Class I	Unichem Pharmaceuticals USA Inc.
Aug 19, 2025	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat...	Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amph...	Class II	Lannett Company Inc.
Aug 11, 2025	Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Dist...	Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained...	Class II	Lannett Company Inc.
Aug 5, 2025	Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled ...	Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, cont...	Class II	Cardinal Health Inc.
Aug 5, 2025	Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIEL...	Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/W...	Class III	Haleon US Holdings LLC
Aug 4, 2025	Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), R...	Lack of Assurance of Sterility.	Class II	PFIZER INC
Aug 4, 2025	Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distri...	Lack of Assurance of Sterility.	Class II	PFIZER INC
Jul 30, 2025	Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech...	CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi...	Class II	Cardinal Health Inc.
Jul 30, 2025	B6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGeni...	Lack of Assurance of Sterility	Class II	GenoGenix LLC
Jul 30, 2025	BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, ...	Lack of Assurance of Sterility	Class II	GenoGenix LLC
Jul 30, 2025	Low Solubility Peptide Reconstitution Solution for Injection, all strengths a...	Lack of Assurance of Sterility	Class II	GenoGenix LLC
Jul 30, 2025	Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South ...	CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi...	Class II	Cardinal Health Inc.
Jul 30, 2025	B-Complex for Injection, all strengths and presentations, GenoGenix, LLC, 284...	Lack of Assurance of Sterility	Class II	GenoGenix LLC
Jul 30, 2025	B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix...	Lack of Assurance of Sterility	Class II	GenoGenix LLC
Jul 30, 2025	Elite Stack Reconstitution Solution for Injection, all strengths and presenta...	Lack of Assurance of Sterility	Class II	GenoGenix LLC
Jul 30, 2025	Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths ...	Lack of Assurance of Sterility	Class II	GenoGenix LLC
Jul 30, 2025	pH Buffered Reconstitution Solution for Injection, all strengths and presenta...	Lack of Assurance of Sterility	Class II	GenoGenix LLC
Jul 30, 2025	Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, Geno...	Lack of Assurance of Sterility	Class II	GenoGenix LLC
Jul 30, 2025	RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Take...	CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi...	Class II	Cardinal Health Inc.
Jul 30, 2025	Glutathione Magnesium for Injection, all strengths and presentations, GenoGen...	Lack of Assurance of Sterility	Class II	GenoGenix LLC
Jul 30, 2025	BPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 284...	Lack of Assurance of Sterility	Class II	GenoGenix LLC
Jul 30, 2025	Bacteriostatic Water for Injection, all strengths and presentations, GenoGeni...	Lack of Assurance of Sterility	Class II	GenoGenix LLC
Jul 30, 2025	Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentatio...	Lack of Assurance of Sterility	Class II	GenoGenix LLC
Jul 30, 2025	NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL mu...	Lack of Assurance of Sterility	Class II	GenoGenix LLC
Jul 30, 2025	Reconstitution XO Solution for Injection, all strengths and presentations, Ge...	Lack of Assurance of Sterility	Class II	GenoGenix LLC
Jul 21, 2025	Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton...	Failed Dissolution Specifications: potential for delayed dissolution of the dose after administra...	Class II	Merck & Co. 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.