Browse Drug Recalls

2,021 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,021 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 2,021 FDA drug recalls.

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DateProductReasonClassFirm
Apr 24, 2018 Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pa... Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F... Class II Prescript Pharmaceuticals, Inc.
Apr 20, 2018 Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-co... Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg containe... Class II Exela Pharma Sciences LLC
Apr 13, 2018 Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed... Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement o... Class III Boiron Inc.
Mar 19, 2018 Tramadol Hydrochloride 50 mg tablets, 120-count, Rx Only; Distributed by Qual... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Lake Erie Medical & Surgical Supply Inc
Mar 19, 2018 Indomethacin Capsules USP, 50 mg, 100-count bottle, Rx Only, Manufactured by:... Labeling: Incorrect Instructions: bottles incorrectly labeled with the usual adult dosage of "One... Class III Glenmark Pharmaceuticals Inc., USA
Mar 15, 2018 All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Co... Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange... Class I Bayer HealthCare Pharmaceuticals, Inc.
Mar 9, 2018 Psoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), pa... Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its lab... Class III Alva-Amco Pharmacal Companies., Inc.
Mar 5, 2018 Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL Compounded ... Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which con... Class III Pine Pharmaceuticals, LLC
Feb 28, 2018 Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count... Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to ... Class III Osmotica Pharmaceutical Corp
Feb 23, 2018 Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%... Labeling: Label mix-up Class II Bayer HealthCare Pharmaceuticals, Inc.
Feb 22, 2018 labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Us... Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indica... Class III SCA Pharmaceuticals, LLC.
Feb 21, 2018 Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 10... Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmoti... Class II Renaissance Lakewood, LLC
Feb 20, 2018 Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multid... Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and ... Class II Hospira Inc. A Pfizer Company
Feb 15, 2018 PVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodi... Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry. Class II Medline Industries Inc
Feb 9, 2018 Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 5... Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Tors... Class II Apace KY LLC
Feb 5, 2018 Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canad... Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitt... Class III Genentech, Inc.
Feb 2, 2018 NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, ... Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classificati... Class III ALLERGAN
Jan 26, 2018 Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules,... Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... Class I Primus Pharmaceuticals, Inc.
Jan 26, 2018 Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules,... Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... Class I Primus Pharmaceuticals, Inc.
Jan 26, 2018 Limbrel (flavocoxid 250 mg) capsules, 60-count bottle, Rx only, Manufactured ... Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... Class I Primus Pharmaceuticals, Inc.
Jan 26, 2018 Limbrel (flavocoxid 500 mg) capsules, 60-count bottle, Rx only, Manufactured ... Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... Class I Primus Pharmaceuticals, Inc.
Jan 22, 2018 Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Mar... Labeling: Label Error on Declared Strength Class II Astellas Pharma US Inc
Jan 22, 2018 Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manuf... Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol Class III Ascent Pharmaceuticals, Inc.
Jan 17, 2018 Senna Laxative (sennosides) tablets, 8.6 mg, 100-count bottles, Manufactured ... Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative conta... Class I Magno Humphries Laboratories, Inc
Jan 11, 2018 Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounde... Labeling: Label Error on Declared Strength Class II Premier Pharmacy Labs Inc
Jan 4, 2018 Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: In... LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogr... Class I International Laboratories, LLC
Dec 7, 2017 Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syring... Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and bey... Class II SCA Pharmaceuticals
Dec 5, 2017 Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count ... Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found p... Class III Sanofi-Aventis U.S. LLC
Dec 4, 2017 Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/... Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg Class II Solco Healtcare US LLC
Nov 20, 2017 Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28... Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil a... Class II Teva Pharmaceuticals USA
Nov 16, 2017 Sermorelin Acetate 3 mg/ GHRP6 3 mg, Lyophilized Vial, Rx Only, KRS Global Bi... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Hydroxocobalamin 1 mg/mL 30 mL Vial For IM Use, Rx Only, KRS Global Biotechno... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Anastrozole SR 1 mg Capsules, Rx Only, KRS Global Biotechnology, 791 Park of ... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 7-Ketodehydroepiandrosterone (7-Keto DHEA) 100 mg Capsule, Rx Only, KRS Globa... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 QUADMIX #16, 5 mL Vial, Rx Only, KRS Global Biotechnology, 791 Park of Commer... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Chloramphenicol 500 mg Amphotericin 50 mg Otic Powder packaged in jars, Rx On... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 T-105 (Prostaglandin E1, 10 mcg/ Papaverine 30 mg/ Phentolamine 1 mg/mL), For... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream packaged in jars, R... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Sermorelin 500 mcg Orally Disintegrating Tablets (ODT), Rx Only, KRS Global B... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Trimix #23F (Prostaglandin E1 6 mcg/ Papaverine HCl 17.8 mg/ Phentolamine Mes... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Human Chorionic Gonadotropin 500 iu Orally Disintegrating Tablets (ODT), Rx O... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Human Chorionic Gonadotropin 20,000 iu/Vial, Lyophilized - For SC Use, Rx Onl... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Human Chorionic Gonadotropin 5,000 iu/ Vial Lyophilized, For SC Use, Rx Only,... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Sermorelin, 3 mg/ GHRP6, 3 mg/GHRP2, 3 mg, Vial - Lyophilized, For SC Use, Rx... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 7-Keto DHEA 25mg Capsule, Rx Only, KRS Global Biotechnology, 791 Park of Comm... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Vitamin 10 B Lyophilized Vial, For IM Use, Rx Only, KRS Global Biotechnology,... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Human Chorionic Gonadotropin 11,000 iu/Vial Lyophilized For SC Use, Rx Only, ... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Amphotericin 60 mg/Chloramphenicol 600 mg/Hydrocortisone 10 mg Otic Powder pa... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 Sincalide 5 mcg Lyophilized Vials, For IV Use, Rx Only, KRS Global Biotechnol... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, Inc
Nov 16, 2017 PrednisoLONE 10 mg Tablet, Rx Only, KRS Global Biotechnology, 791 Park of Com... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, 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.