Browse Drug Recalls

2,116 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,116 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 2,116 FDA drug recalls in NJ.

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Date	Product	Reason	Class	Firm
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.
Feb 24, 2017	Penicillin V Potassium Tablets, USP 500 mg (800,000 units) 1000 count bottles...	Presence of Foreign Tablet/Capsule; Amoxicillin 500 mg was found in bottles of Penicillin V potas...	Class III	Citron Pharma Llc
Feb 22, 2017	Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not f...	Chemical Contamination	Class III	Novel Laboratories, Inc.
Feb 21, 2017	A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, Packaged in a) ...	Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a label...	Class III	Bayer HealthCare Pharmaceuticals, Inc.
Feb 15, 2017	Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 1...	Failed dissolution specifications - low dissolution results at S3 stage.	Class III	Dr. Reddy's Laboratories, Inc.
Feb 15, 2017	Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 1...	Failed dissolution specifications - low dissolution results at S3 stage.	Class III	Dr. Reddy's Laboratories, Inc.
Feb 15, 2017	Zenatane (isotretinoin) capsules, 30 mg, packaged in 30-count cartons (3 x 1...	Failed dissolution specifications - low dissolution results at S3 stage.	Class III	Dr. Reddy's Laboratories, Inc.
Feb 15, 2017	Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 1...	Failed dissolution specifications - low dissolution results at S3 stage.	Class III	Dr. Reddy's Laboratories, Inc.
Feb 10, 2017	Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx o...	Failed Dissolution Specifications	Class II	Sandoz Inc
Feb 7, 2017	Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in b...	Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and ...	Class II	G & W Laboratories, Inc.
Feb 7, 2017	Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx...	Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at...	Class III	Actavis Inc
Feb 2, 2017	Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (N...	Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stat...	Class II	Sandoz Inc
Jan 30, 2017	Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufa...	Failed Dissolution Specifications. Above out of specification for dissolution rate observed at th...	Class II	Actavis Inc
Jan 19, 2017	Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) ...	Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized...	Class II	LEO PHARMA INC
Jan 16, 2017	Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, ...	Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-...	Class III	LEO PHARMA INC
Jan 12, 2017	Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottl...	Failed Dissolution Specifications	Class II	Sun Pharmaceutical Industries, Inc.
Jan 12, 2017	Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vial...	Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.	Class III	Actavis Inc
Jan 9, 2017	Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd. By: Dr...	Defective Container: Product complaints received of defect in the seal of the Docetaxel injection...	Class II	Dr. Reddy's Laboratories, Inc.
Jan 7, 2017	Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for...	Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue ...	Class III	Hetero USA Inc
Jan 5, 2017	Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, R...	Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet ident...	Class II	Sun Pharmaceutical Industries, Inc.
Dec 28, 2016	Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 c...	Failed Dissolution Specifications; 18 month stability time point	Class II	Dr. Reddy's Laboratories, Inc.
Dec 28, 2016	Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 c...	Failed Dissolution Specifications; 18 month stability time point	Class II	Dr. Reddy's Laboratories, Inc.
Dec 28, 2016	Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 co...	Failed Dissolution Specifications; 18 month stability time point	Class II	Dr. Reddy's Laboratories, Inc.
Dec 28, 2016	Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. R...	Failed Dissolution Specifications; 18 month stability time point	Class II	Dr. Reddy's Laboratories, Inc.
Dec 22, 2016	Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottle...	Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted caps...	Class II	Aurobindo Pharma USA Inc
Dec 20, 2016	buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count ...	Failed Dissolution Specifications; 18 month stability time point	Class III	Sun Pharmaceutical Industries, Inc.
Dec 20, 2016	buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (ND...	Failed Dissolution Specifications; 18 month stability time point	Class III	Sun Pharmaceutical Industries, Inc.
Dec 16, 2016	Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only,...	Discoloration: Some vials were found to contain powder with a yellowish-brownish appearance.	Class III	Aurobindo Pharma USA Inc
Dec 13, 2016	Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC ...	Subpotent Drug: out of specification results for assay test.	Class III	Sandoz Inc
Dec 9, 2016	SLIMFIT X capsules, packaged in a 60-cont bottle	Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and desmethylsibut...	Class I	Jersey Shore Supplements, LLC
Nov 18, 2016	CVS Health Homeopathic Infants Teething Tablets 135 count bottle Distributed...	CGMP Deviations	Class II	Raritan Pharmaceuticals, Inc.
Nov 18, 2016	CVS pharmacy Kids' Ear Relief Oral Liquid 0.85 oz (25 mL) Distributed by: CVS...	CGMP Deviations	Class II	Raritan Pharmaceuticals, Inc.
Nov 18, 2016	Kids' Relief Ear Relief Oral Liquid 0.85 fl oz. (25 mL) 3025 de'l Assomption...	CGMP Deviations	Class II	Raritan Pharmaceuticals, Inc.
Nov 17, 2016	SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5...	Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 mon...	Class III	West-Ward Pharmaceuticals Corp.
Nov 9, 2016	L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single...	Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns...	Class II	Sandoz Inc
Nov 9, 2016	L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Packag...	Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns...	Class II	Sandoz Inc
Nov 4, 2016	Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted)...	Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the stren...	Class III	West-Ward Pharmaceuticals Corp.
Nov 2, 2016	Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactu...	Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of...	Class II	Ascend Laboratories LLC
Nov 2, 2016	BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 3...	Failed Dissolution Specifications; 6 month time point	Class III	Zydus Pharmaceuticals USA Inc
Oct 28, 2016	Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-7...	CGMP Deviations: manufactured under practices which may result in assay or content uniformity fai...	Class II	Nationwide Laboratories, LLC
Oct 28, 2016	Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-7...	CGMP Deviations: manufactured under practices which may result in assay or content uniformity fai...	Class II	Nationwide Laboratories, LLC
Oct 28, 2016	Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx onl...	CGMP Deviations: manufactured under practices which may result in assay or content uniformity fai...	Class II	Nationwide Laboratories, LLC
Oct 28, 2016	KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP,...	Failed Stability Specifications: Low Out of Specification results for alcohol content.	Class III	Sun Pharmaceutical Industries, Inc.
Oct 28, 2016	Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx onl...	CGMP Deviations: manufactured under practices which may result in assay or content uniformity fai...	Class II	Nationwide Laboratories, 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.