Browse Drug Recalls

2,109 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,109 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 2,109 FDA drug recalls in NJ.

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DateProductReasonClassFirm
May 9, 2017 Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Str... Failed Stability Specifications: Out of Specification results obtained for preservative Methylpar... Class III Strides Pharma INC
May 5, 2017 AMLODIPINE BESYLATE TABLET, USP, 10 mg, 1000 count bottle, Rx Only, Manufactu... PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled w... Class III Ascend Laboratories LLC
Apr 27, 2017 Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: ... Presence of Foreign Substance: human hair melded into tablet. Class III Hetero USA Inc
Apr 26, 2017 Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 coun... Subpotent Drug; Clavulanic Acid Class III Sandoz Inc
Apr 20, 2017 Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Apr 20, 2017 Phenobarbital Tablets USP, 60 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Apr 20, 2017 Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactur... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Apr 20, 2017 Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Apr 20, 2017 Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital... Class I C. O. Truxton
Apr 20, 2017 Phenobarbital Tablets USP, 30 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Label Mixup; potentially mislabeled Class I C. O. Truxton
Apr 18, 2017 Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, ... Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness. Class III Sun Pharmaceutical Industries, Inc.
Apr 18, 2017 Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, ... Microbial Contamination of Non-Sterile Products Class II Sun Pharmaceutical Industries, Inc.
Apr 13, 2017 Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg con... CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall n... Class II Spectrum Laboratory Products, Inc.
Apr 13, 2017 Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Pl... CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall n... Class II Spectrum Laboratory Products, Inc.
Apr 7, 2017 Desoximetasone Ointment USP, 0.25%, 15 g tubes, Rx Only, Teligent Pharma, In... Superpotent Drug Class III Teligent, Inc.
Apr 3, 2017 Refresh Tears (Carboxymethylcellulose Sodium Solution) 0.5%, Lubricant Eye Dr... Labeling: Not elsewhere classified; product labeling lacks a NDC number, net weight information a... Class II Cell Distributors
Mar 30, 2017 Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium... Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister... Class II Bayer HealthCare Pharmaceuticals, Inc.
Mar 30, 2017 Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium b... Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister... Class II Bayer HealthCare Pharmaceuticals, Inc.
Mar 30, 2017 Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bic... Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister... Class II Bayer HealthCare Pharmaceuticals, Inc.
Mar 22, 2017 Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles,... Failed Impurities/Degradation Specifications. Class III Novartis Pharmaceuticals Corp.
Mar 22, 2017 Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83)... Failed Impurities/Degradation Specifications: out of specification results for the related substa... Class III Sun Pharmaceutical Industries, Inc.
Mar 22, 2017 Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83)... Failed Impurities/Degradation Specifications: out of specification results for the related substa... Class III Sun Pharmaceutical Industries, Inc.
Mar 22, 2017 Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun ... Failed Impurities/Degradation Specifications: out of specification results for the related substa... Class III Sun Pharmaceutical Industries, Inc.
Mar 22, 2017 Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in... Failed Impurities/Degradation Specifications. Class III Novartis Pharmaceuticals Corp.
Mar 22, 2017 Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83... Failed Impurities/Degradation Specifications: out of specification results for the related substa... Class III Sun Pharmaceutical Industries, Inc.
Mar 20, 2017 Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638... Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert. Class III G & W Laboratories, Inc.
Mar 20, 2017 CLENZIderm M.D. Acne Treatment System, kit has 3 bottles a) Therapeutic Lotio... Discoloration. Class III Valeant Pharmaceuticals North America LLC
Mar 20, 2017 CLENZIderm M.D. Pore Therapy Salicylic Acid 2% Acne Treatment 5 fl. oz. (148 ... Discoloration. Class III Valeant Pharmaceuticals North America LLC
Mar 15, 2017 Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68... Failed Dissolution Specifications; 9 month long term stability Class II Zydus Pharmaceuticals USA Inc
Mar 15, 2017 Testosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramusc... Presence of Particulate Matter Class II Sun Pharmaceutical Industries, Inc.
Mar 10, 2017 Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Clari... Lack of Assurance of Sterility: there is potential of a leak from the primary container which may... Class II Claris Lifesciences Inc
Mar 10, 2017 Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, ... Lack of Assurance of Sterility: there is potential of a leak from the primary container which may... Class II Claris Lifesciences Inc
Mar 10, 2017 Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only... Lack of Assurance of Sterility: there is potential of a leak from the primary container which may... Class II Claris Lifesciences Inc
Mar 10, 2017 Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Clar... Lack of Assurance of Sterility: there is potential of a leak from the primary container which may... Class II Claris Lifesciences Inc
Mar 7, 2017 Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx... Cross Contamination with another product:residual powder found in inlet air duct identified as so... Class III Alvogen, Inc
Mar 7, 2017 Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900... Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at ... Class III Pfizer Inc
Mar 7, 2017 Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300... Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at ... Class III Pfizer Inc
Mar 7, 2017 Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx... Cross Contamination with another product:residual powder found in inlet air duct identified as so... Class III Alvogen, Inc
Mar 7, 2017 Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx... Cross Contamination with another product:residual powder found in inlet air duct identified as so... Class III Alvogen, Inc
Mar 7, 2017 Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx... Cross Contamination with another product:residual powder found in inlet air duct identified as so... Class III Alvogen, Inc
Mar 7, 2017 Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manuf... Cross Contamination with another product:residual powder found in inlet air duct identified as so... Class III Alvogen, Inc
Mar 7, 2017 Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, ... Cross Contamination with another product:residual powder found in inlet air duct identified as so... Class III Alvogen, Inc
Mar 7, 2017 Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx ... Cross Contamination with another product:residual powder found in inlet air duct identified as so... Class III Alvogen, Inc
Mar 7, 2017 Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manuf... Cross Contamination with another product:residual powder found in inlet air duct identified as so... Class III Alvogen, Inc
Mar 7, 2017 Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750... Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at ... Class III Pfizer Inc
Mar 7, 2017 Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manuf... Cross Contamination with another product:residual powder found in inlet air duct identified as so... Class III Alvogen, Inc
Mar 6, 2017 RIVASTIGMINE Tartrate Capsules, USP, 1.5 mg, 60-count bottle, Rx Only, Mfd. B... Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsul... Class III Dr. Reddy's Laboratories, Inc.
Mar 6, 2017 Sensodyne Repair & Protect Whitening, (stannous fluoride 0.45% (0.15% w/v flu... Presence of Foreign Substance; low concentration of an additional flavoring ingredient, Patchouli... Class II GSK Consumer Healthcare
Mar 6, 2017 ATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023... Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets ... Class II Zydus Pharmaceuticals USA Inc
Feb 28, 2017 Clindamycin Phosphate Topical Solution USP, 1%, packaged in a) 30 mL applicat... CGMP Deviations: an expired active ingredient was used in the manufacture of these recalled lots. Class III G & W Laboratories, 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.