Browse Drug Recalls

2,193 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,193 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 2,193 FDA drug recalls in NJ.

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DateProductReasonClassFirm
Oct 15, 2012 AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v)... Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the benzoyl peroxi... Class III Valeant Pharmaceuticals
Oct 15, 2012 AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads pe... Subpotent (Single Ingredient) Drug: This product was found to be subpotent for the salicyclic aci... Class III Valeant Pharmaceuticals
Sep 27, 2012 Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd B... Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 mon... Class II Dr. Reddy's Laboratories, Inc.
Sep 6, 2012 Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, ... CGMP Deviations: Product was made with an incorrect ingredient, Laureth-9 was mistakenly substitu... Class II Church & Dwight Inc
Sep 4, 2012 Simply Right Healthcare Fiber Capsules, 100% Natural Psyllium Fiber, Fiber Su... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, Inc.
Sep 4, 2012 Up&Up Psyllium Fiber Supplement, 100% natural psyllium husk, Fiber Therapy fo... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, Inc.
Sep 4, 2012 Premier Value Fiber Plus Calcium Supplement Capsules, 120 capsules per bottle... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, Inc.
Sep 4, 2012 DRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber, Mfg. b... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, Inc.
Sep 4, 2012 CVS Pharmacy Fiber Capsules for Regularity, Dietary Fiber Supplement, 100 Cap... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, Inc.
Sep 4, 2012 Best Choice Health Care, Psyllium Fiber Supplement, 100% natural Psyllium Fib... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, Inc.
Sep 4, 2012 Wal-Mucil Plus Calcium Fiber Capsules,100% Natural Fiber, 100% Natural Psylli... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, Inc.
Sep 4, 2012 Berkley & Jensen Fiber Capsules, Fiber Laxative/Fiber Supplement, 100% Natura... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, Inc.
Sep 4, 2012 Equate Fiber Therapy, 100% Natural Psyllium Husk Fiber, Fiber Laxative/Fiber ... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, Inc.
Sep 4, 2012 Wal-Mucil 100% Natural Fiber, 100% Natural Psyllium Seed Husk, Fiber Laxative... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, Inc.
Sep 4, 2012 Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Su... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, Inc.
Sep 4, 2012 Premier Value Fiber Capsules, Fiber Capsules, 100% Natural Psyllium Fiber, Re... Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microb... Class II Raritan Pharmaceuticals, Inc.
Aug 29, 2012 BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactu... Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine v... Class I Bristol-myers Squibb Company
Aug 23, 2012 Novarel¿ (Chorionic Gonadotropin for injection, USP), 10,000 USP FOR INTRAMUS... Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warn... Class III Ferring Pharmaceuticals Inc
Aug 21, 2012 Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count u... Crystallization: Presence of crystals of Nimodipine within the capsule solution. Class II Caraco Pharmaceutical Laboratories Ltd.
Aug 21, 2012 Atorvastatin Calcium Tablets, 10 mg, 90-count tablets per bottle, Rx only, Ma... Adulterated Presence of Foreign Tablets: A product complaint was received by a pharmacist who dis... Class II Ranbaxy Inc.
Aug 14, 2012 Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials ... Presence of Particulate Matter; potential for charcoal particulates Class III Bracco Diagnostic Inc
Aug 1, 2012 Citalopram tablets USP, 20mg, 30-count bottle, Rx only, Manufactured by Dr. R... Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic... Class II Dr. Reddy's Laboratories, Inc.
Aug 1, 2012 Citalopram tablets USP, 10mg, 30-count bottle, Rx only, Manufactured by Dr. ... Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic... Class II Dr. Reddy's Laboratories, Inc.
Aug 1, 2012 Citalopram tablets USP, 40mg, 30-count bottle, Rx only, Manufactured by Dr. R... Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic... Class II Dr. Reddy's Laboratories, Inc.
Jul 6, 2012 NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufact... Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90... Class II Glenmark Generics Inc., USA
Jun 5, 2012 Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physi... Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly... Class II Bristol-myers Squibb Company
Jun 5, 2012 Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physi... Labeling; Correct labeled product miscart/mispack: Some Physician sample cartons were incorrectly... Class II Bristol-myers Squibb Company
Jun 1, 2012 CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution... GMP deviation; Sr-82 levels exceeded alert limit specification Class II Bracco Diagnostics Inc
May 8, 2012 Estradiol Hemihydrate M20 EP/USP Powder, packaged in a) 1.5 kg and b) 2.5 kg ... Cross Contamination w/Other Products: This active pharmaceutical ingredient is being recalled due... Class II Bayer HealthCare Pharmaceuticals Inc.
Apr 26, 2012 Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a)... Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on t... Class III Bayer Healthcare, LLC
Apr 26, 2012 Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Gelcaps 24 ct. b... Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on t... Class III Bayer Healthcare, LLC
Apr 16, 2012 Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy ... Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap du... Class II Bracco Diagnostics Inc
Apr 16, 2012 Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, ... Short Fill: The product is being recalled due to a potential underfill of the affected vials. Class III Bracco Diagnostics Inc
Apr 13, 2012 Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 m... Presence of Particulate Matter: This product is being recalled due to the discovery of particles ... Class II West-ward Pharmaceutical Corp.
Apr 13, 2012 Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10... Presence of Particulate Matter: This product is being recalled due to the discovery of particles ... Class II West-ward Pharmaceutical Corp.
Apr 9, 2012 Dr. Reddy's Ciprofloxacin Tablets, USP 500 mg*, 500 Tablets, Rx only, Mfd. By... Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of misl... Class II Dr. Reddy's Laboratories, Inc.
Apr 9, 2012 Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20 mg, 50... Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of misl... Class II Dr. Reddy's Laboratories, Inc.
Mar 16, 2012 Balnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution,... Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay. Class III Ranbaxy Inc.
Mar 14, 2012 Metformin Hydrochloride Tablets, USP, 1000 mg, Rx only, 1000 count tablets pe... Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discover... Class II Zydus Pharmaceuticals USA Inc
Feb 6, 2012 Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. fo... CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, w... Class II sanofi-aventis US, Inc.
Feb 6, 2012 Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for:... CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, w... Class II sanofi-aventis US, Inc.
Dec 2, 2011 Argatroban Injection 50 mg per 50ml (1 mg per ml) For Intravenous Infusion O... A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a s... Class I Eagle Pharmaceuticals Inc.
Oct 17, 2011 Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC indus... Labeling: Presence of Undeclared Color Additive; The product is being recalled because several in... Class II Meda Pharmaceuticals 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.