Browse Drug Recalls

1,680 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,680 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 1,680 FDA drug recalls — Class III.

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Date	Product	Reason	Class	Firm
Feb 21, 2020	Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: A...	Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identi...	Class III	Akorn, Inc.
Feb 17, 2020	Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count b...	Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chlor...	Class III	Strides Pharma Science Limited
Feb 14, 2020	Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 m...	Labeling: Incorrect or Missing Lot and/or Expiration date.	Class III	AAA Pharmaceutical, Inc.
Feb 12, 2020	TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC ...	Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets ...	Class III	Golden State Medical Supply Inc.
Feb 10, 2020	Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablet...	Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiratio...	Class III	Par Pharmaceutical Inc.
Feb 7, 2020	Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose...	Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found ...	Class III	AuroMedics Pharma LLC
Jan 29, 2020	Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufa...	Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure...	Class III	UNICHEM PHARMACEUTICALS USA INC
Jan 28, 2020	Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottl...	Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets ...	Class III	Teva Pharmaceuticals USA
Jan 24, 2020	Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, ...	Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitaz...	Class III	Macleods Pharma Usa Inc
Jan 22, 2020	Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bo...	Failed Dissolution Specifications: low out of specification results for dissolution testing.	Class III	Ascend Laboratories LLC
Jan 20, 2020	Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufac...	Failed Dissolution Specifications: testing revealed low out of specification result in one lot o...	Class III	Macleods Pharma Usa Inc
Jan 15, 2020	Magnesium Chloride Injection, MAGNESIUM CHLORIDE 20% INJECTABLE, For IV Use,...	Lack of Assurance of Sterility	Class III	Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 14, 2020	methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only...	Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to rec...	Class III	Hikma Pharmaceuticals USA Inc.
Jan 10, 2020	Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.0...	CGMP Deviations: Out of specification test result observed during retrospective review of blend u...	Class III	Lupin Pharmaceuticals Inc.
Jan 7, 2020	Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET W...	Microbial contamination of non-sterile product.	Class III	Sigan Industries Inc.
Dec 26, 2019	Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper ...	Chemical contamination; out of specification results obtained for equipment cleaning residue rins...	Class III	Akorn, Inc.
Dec 20, 2019	PCA Skin Blemish Control Bar, 3.2 oz/90g, Salicylic acid 2% - Acne cleanser, ...	Superpotent Drug: Salicylic acid content is above the firm's specification.	Class III	Island Kinetics, Inc. d.b.a. CoValence Laborato...
Dec 16, 2019	NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 ...	Subpotent Drug	Class III	Pharmedium Services, LLC
Dec 16, 2019	NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 ...	Subpotent Drug	Class III	Pharmedium Services, LLC
Dec 16, 2019	NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 ...	Subpotent Drug	Class III	Pharmedium Services, LLC
Dec 13, 2019	Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx...	Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other i...	Class III	Lupin Pharmaceuticals Inc.
Dec 13, 2019	Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-coun...	Failed Dissolution Specifications: High out of specification result observed at stability studies.	Class III	The Harvard Drug Group
Dec 10, 2019	Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-co...	Failed Dissolution Specifications: High out of specification result observed at stability studies.	Class III	Lupin Pharmaceuticals Inc.
Dec 2, 2019	Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For...	Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.	Class III	AuroMedics Pharma LLC
Nov 25, 2019	VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 ...	Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the pro...	Class III	Apothecus Pharmaceutical Corp.
Nov 20, 2019	SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net...	Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient...	Class III	Idelle Labs
Nov 20, 2019	SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net W...	Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient...	Class III	Idelle Labs
Nov 20, 2019	SURE 48hr Confidence Nourishing Coconut invisible solid Antiperspirant & Deod...	Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient...	Class III	Idelle Labs
Nov 20, 2019	SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant, ...	Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient...	Class III	Idelle Labs
Nov 15, 2019	Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68...	Defective delivery system; product is not foaming or is coming out as liquid.	Class III	Glenmark Pharmaceuticals Inc., USA
Nov 15, 2019	Clobetasol Propionate Foam, 0.05%, a) 50 g pack (NDC 68462-608-27) and b) 100...	Defective delivery system; product is not foaming or is coming out as liquid.	Class III	Glenmark Pharmaceuticals Inc., USA
Nov 15, 2019	Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topi...	Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had...	Class III	Rising Pharmaceuticals, Inc.
Nov 15, 2019	Colostat, Homeopathic Remedy, 1 fl. oz. (30 mL) per bottle, 20% Ethanol, Dist...	Labeling mix-up - Indications on product label are incorrect.	Class III	Grato Holdings, Inc.
Nov 15, 2019	Timolol Maleate USP, 0.5%, 5 mL, Sterile Opthalmic Solution, Rx Only, For T...	Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had...	Class III	Rising Pharmaceuticals, Inc.
Nov 11, 2019	Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL S...	Crystallization: Presence of visible particulate matter.	Class III	AuroMedics Pharma LLC
Nov 11, 2019	Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL S...	Crystallization: Presence of visible particulate matter.	Class III	AuroMedics Pharma LLC
Nov 11, 2019	Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL...	Crystallization: Presence of visible particulate matter.	Class III	AuroMedics Pharma LLC
Nov 1, 2019	Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufact...	Presence of Foreign substance: identified as a dead ant.	Class III	Lupin Pharmaceuticals Inc.
Nov 1, 2019	Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manuf...	Presence of Foreign substance: identified as a dead ant.	Class III	Lupin Pharmaceuticals Inc.
Nov 1, 2019	Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (ND...	Presence of Foreign substance: identified as a dead ant.	Class III	Lupin Pharmaceuticals Inc.
Oct 22, 2019	Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manuf...	Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Ato...	Class III	Apotex Inc.
Oct 21, 2019	PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, ...	Incorrect labeling: Incorrect or missing lot and/or exp date	Class III	Nephron Pharmaceuticals Corporation dba Nephron...
Oct 17, 2019	Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Ste...	Labeling: Incorrect or missing package insert.	Class III	Sandoz Inc
Oct 17, 2019	Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx...	Labeling: Incorrect or missing package insert.	Class III	Sandoz Inc
Oct 17, 2019	Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to th...	Labeling: Incorrect or missing package insert.	Class III	Sandoz Inc
Oct 16, 2019	Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10...	Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.	Class III	Amneal Pharmaceuticals, Inc.
Oct 11, 2019	Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manuf...	Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.	Class III	X-Gen Pharmaceuticals Inc.
Oct 4, 2019	Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar...	Presence of Foreign Substance; Fiber particles.	Class III	KVK-Tech, Inc.
Oct 1, 2019	Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distribute...	Subpotent Drug	Class III	Sato Pharmaceutical Inc.
Oct 1, 2019	WAL-DRAM 2 (meclizine Hydrochloride) 25 mg tablets, packaged in a) 12 count (...	Subpotent Drug	Class III	Sato Pharmaceutical 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.