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 |
|---|---|---|---|---|
| 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 |
| Oct 19, 2016 | Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM ... | Labeling: Missing Label | Class III | Sandoz Inc |
| Oct 18, 2016 | HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepare... | Subpotent Drug: due to failed potency results of 74% (spec. 80-125%). | Class III | Town and Country Compounding and Consultation S... |
| Oct 18, 2016 | Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 O... | Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of... | Class III | GSK Consumer Healthcare |
| Oct 13, 2016 | Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd:... | Failed impurities/degradation specifications: due to out-of-specification result for the Related ... | Class III | Dr. Reddy's Laboratories, Inc. |
| Oct 6, 2016 | NIFEdipine Capsules USP, 10 mg, Rx only, 100 count bottle, Manufactured and d... | Presence of Foreign Tablets/Capsules | Class III | Actavis Elizabeth LLC |
| Oct 3, 2016 | Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-War... | Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolu... | Class II | West-Ward Pharmaceuticals Corp. |
| Sep 13, 2016 | buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-D... | Failed Dissolution Specifications | Class III | Sun Pharmaceutical Industries, Inc. |
| Sep 8, 2016 | GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Singl... | Defective delivery system: detached needles on the syringe in the kit. | Class I | Novo Nordisk Inc |
| Sep 1, 2016 | Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx ... | Labeling: Incorrect or Missing Package Insert | Class III | Sanofi-Aventis U.S. LLC |
| Aug 29, 2016 | ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Aug 24, 2016 | Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 6675... | Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns... | Class II | Sandoz Inc |
| Aug 24, 2016 | Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 ... | Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns... | Class II | Sandoz Inc |
| Aug 24, 2016 | Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pac... | Defective Delivery System; reports of damaged product that may alter the predicted release of sco... | Class II | Sandoz Inc |
| Aug 19, 2016 | Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Man... | Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets. | Class III | Unichem Pharmaceuticals Usa Inc |
| Aug 18, 2016 | Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when re... | Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of... | Class III | West-Ward Pharmaceuticals Corp. |
| Aug 4, 2016 | Mozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For... | Labeling: Incorrect or Missing Lot and/or Exp. Date | Class III | Genzyme Corporation / Genzyme Biosurgery |
| Aug 3, 2016 | BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, ... | Failed Dissolution Specifications: Product did not meet dissolution specification at an intermedi... | Class III | Zydus Pharmaceuticals USA Inc |
| Aug 3, 2016 | Mucinex Sinus-Max Day Night, 60 caplets, Dist. by Reckitt Benckiser, Parsippa... | Labeling: Label Error on Declared Strength; label on outer carton incorrectly states Diphenhydram... | Class III | Reckitt Benckiser LLC |
| Aug 3, 2016 | Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets pe... | Presence of Foreign Tablets/Capsules: Firm received a market complaint stating the presence of on... | Class II | Aurobindo Pharma USA Inc |
| Aug 2, 2016 | Hydrocortisone and acetic acid otic solution, Rx only, 10 mL bottle, Distribu... | Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related comp... | Class III | Actavis Inc |
| Aug 2, 2016 | Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 ... | Failed Impurities/Degradation Specifications: Out of specification (OOS) results for related comp... | Class III | Actavis Inc |
| Aug 1, 2016 | Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and ... | Non-Sterility; microbial contamination identified as Bacillus circulans | Class I | Town and Country Compounding and Consultation S... |
| Aug 1, 2016 | Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical M... | Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits. | Class II | Spectrum Laboratory Products, 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.