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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.