Browse Drug Recalls

2,012 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,012 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 2,012 FDA drug recalls.

Clear
DateProductReasonClassFirm
May 19, 2020 Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured ... CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... Class II Wuhan Bingbing Pharmaceutical Co., Ltd.
May 19, 2020 LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches pe... CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... Class II Wuhan Bingbing Pharmaceutical Co., Ltd.
Apr 20, 2020 ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ... Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... Class III Glaxosmithkline Consumer Healthcare Holdings
Apr 20, 2020 ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08... Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... Class III Glaxosmithkline Consumer Healthcare Holdings
Apr 20, 2020 ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ... Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... Class III Glaxosmithkline Consumer Healthcare Holdings
Mar 16, 2020 Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops ... Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... Class II Glaxosmithkline Consumer Healthcare Holdings
Mar 16, 2020 Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F005... Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... Class II Glaxosmithkline Consumer Healthcare Holdings
Mar 16, 2020 Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with... Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... Class II Glaxosmithkline Consumer Healthcare Holdings
Mar 16, 2020 Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. A... Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... Class II Glaxosmithkline Consumer Healthcare Holdings
Mar 16, 2020 Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bot... Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... Class II Glaxosmithkline Consumer Healthcare Holdings
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

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.