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 6, 2020	Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, ...	CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/...	Class II	Nostrum Laboratories Inc
Mar 4, 2020	PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par...	Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Pre...	Class III	Par Pharmaceutical Inc.
Mar 3, 2020	PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g...	Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for ...	Class II	Yusef Manufacturing Laboratories, LLC
Feb 27, 2020	Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dos...	Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q...	Class III	The Harvard Drug Group
Feb 27, 2020	Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit do...	Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q...	Class III	The Harvard Drug Group
Feb 27, 2020	Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit do...	Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q...	Class III	The Harvard Drug Group
Feb 27, 2020	Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit do...	Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q...	Class III	The Harvard Drug Group
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	Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only...	Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may ...	Class I	Taro Pharmaceuticals U.S.A., Inc.
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	Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufact...	Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tabl...	Class II	Graviti Pharmaceuticals Private Limited
Jan 28, 2020	Kushim Tablets (Gushim) 45-count packages, Label in foreign language	Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin...	Class II	B AND A TRADING CORPORATION
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 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.
Dec 27, 2019	Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repacka...	Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer...	Class I	RemedyRepack Inc.
Dec 23, 2019	Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per car...	Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the prod...	Class II	GSK Consumer Health, Inc
Dec 18, 2019	Liothyronine (T3) 80 mcg SR cap	Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired...	Class II	MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019	T3/T4 SR 9 mcg/38 mcg capsule	Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired...	Class II	MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019	Tadalafil 20 mg Troche	Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired...	Class II	MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019	DHEA/Pregnenol One 10.25 MG Cap	Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired...	Class II	MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019	Liothyronine (T3) 92.5 MCG	Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired...	Class II	MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019	Progesterone 50 mg capsules	Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired...	Class II	MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019	Sildenafil 200 mg Troche (Clinic)	Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired...	Class II	MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019	Magic Bullet Supplement	Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired...	Class II	MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019	Finasteride/Biotin 1 mg/50 mcg	Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired...	Class II	MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019	Testosterone Topical Cream 4%	Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired...	Class II	MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019	Progesterone E4M SR 100 mg capsules	Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired...	Class II	MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019	Sildenafil 80 mg capsules	Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired...	Class II	MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019	Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars	Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired...	Class II	MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019	Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars	Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired...	Class II	MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019	Naltrexone 4.5 mg capsule	Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired...	Class II	MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019	Tadalafil 6 mg Capsule	Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired...	Class II	MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019	Progesterone 200 mg Troche	Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired...	Class II	MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019	Squaric Acid 0.1% Topical Solution (Clinic) 30 mL	Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired...	Class II	MPRX, Inc. dba Medical Park Pharmacy
Nov 27, 2019	25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only,...	Labeling: Incorrect or Missing Lot and/or expiration date.	Class II	Pfizer Inc.
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 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	Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by...	Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bo...	Class I	AuroMedics Pharma LLC
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	Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by:...	Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bo...	Class I	AuroMedics Pharma LLC
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	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 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	MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3...	Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP ...	Class II	Akorn, 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.
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	Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to th...	Labeling: Incorrect or missing package insert.	Class III	Sandoz Inc
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

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.