Browse Drug Recalls

2,101 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,101 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 2,101 FDA drug recalls in NJ.

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Date	Product	Reason	Class	Firm
Nov 29, 2017	Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Z...	Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets...	Class II	Prinston Pharmaceutical Inc
Nov 20, 2017	Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count...	Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets	Class II	Zydus Pharmaceuticals USA Inc
Nov 20, 2017	Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: G...	CGMP Deviations: Market complaints related to "gritty texture".	Class II	Glenmark Pharmaceuticals Inc., USA
Nov 13, 2017	Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by:...	Failed Impurities/Degradation Specifications	Class III	Elite Laboratories Inc.
Nov 11, 2017	Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 ...	Superpotent	Class III	Renaissance Lakewood, LLC
Nov 10, 2017	Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spa...	Failed Stability Specifications	Class III	Bayer HealthCare Pharmaceuticals, Inc.
Nov 6, 2017	Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Via...	Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone...	Class III	West-Ward Pharmaceuticals Corp.
Nov 6, 2017	Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, ...	Superpotent	Class III	Claris Lifesciences Inc
Nov 6, 2017	Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-...	Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone...	Class III	West-Ward Pharmaceuticals Corp.
Oct 30, 2017	Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol, (lidocaine 4%, me...	Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt...	Class III	Dr. Reddy's Laboratories, Inc.
Oct 13, 2017	Clofarabine injection, 20 mg/20 mL, 20 mL Single-Use Vial, Rx only, Mfd by: T...	Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the i...	Class III	Sanofi-Aventis U.S. LLC
Oct 3, 2017	Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CV...	Failed impurities/degradation specifications: Famotodine has an out of specification result for a...	Class III	Dr. Reddy's Laboratories, Inc.
Oct 2, 2017	Bisoprolol Fumarate tablets, 5 mg, 30-count bottles, Rx only, Manufactured ...	Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was o...	Class II	Unichem Pharmaceuticals Usa Inc
Sep 28, 2017	Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured b...	Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablet...	Class II	Leading Pharma, LLC
Sep 25, 2017	Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78...	Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap ...	Class III	Sandoz Inc
Sep 15, 2017	ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v ...	Labeling; Label Mixup; the immediate package is labeled incorrectly as Chloroprep Onestep (Clear)...	Class II	Becton Dickinson & Company
Aug 23, 2017	Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Univer...	GMP Deviations; potential bacterial contamination may have been introduced to products through a ...	Class II	Inopak Ltd
Aug 23, 2017	Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X., 1000 mL and 2000 mL Dis...	GMP Deviations; potential bacterial contamination may have been introduced to products through a ...	Class II	Inopak Ltd
Aug 23, 2017	Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18...	GMP Deviations; potential bacterial contamination may have been introduced to products through a ...	Class II	Inopak Ltd
Aug 22, 2017	Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufacture...	Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specificatio...	Class III	Wockhardt Usa Inc.
Aug 18, 2017	Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cad...	Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets	Class II	Zydus Pharmaceuticals USA Inc
Jul 20, 2017	Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for...	Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/...	Class II	Hetero USA Inc
Jul 11, 2017	Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC ...	Failed Impurities/Degradation Specifications: high out of specification results for related impur...	Class III	Dr. Reddy's Laboratories, Inc.
Jun 28, 2017	Obagi-C Rx System C-Therapy Night Cream, Net wt. 2 oz. (57g) bottle, Rx only,...	Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being ...	Class III	Valeant Pharmaceuticals North America LLC
Jun 28, 2017	parodontax WHITENING (Stannous fluoride) Daily Fluoride Anticavity and Antigi...	Presence of Foreign Substance: possibility of the presence of metal in the product.	Class II	GSK Consumer Healthcare
Jun 16, 2017	Clindamycin Injection USP; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANT...	Lack of Assurance of Sterility	Class II	Alvogen, Inc
Jun 16, 2017	Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANT...	Lack of Assurance of Sterility	Class II	Alvogen, Inc
Jun 16, 2017	Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANT...	Lack of Assurance of Sterility	Class II	Alvogen, Inc
Jun 15, 2017	Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. ...	Defective container: Oral solution leaking from container.	Class II	Tris Pharma Inc.
Jun 12, 2017	Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor C...	Superpotent Drug: high out-of-specification result for magnesium.	Class III	Sanofi-Aventis U.S. LLC
Jun 5, 2017	EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squ...	Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eli...	Class I	Bristol-myers Squibb Company
Jun 2, 2017	G & W Clobetasol Propionate Ointment 0.05%, packaged in a) 15 g tube (NDC 071...	Failed impurities/degradation specifications: This product is being recalled due to out of specif...	Class III	G & W Laboratories, Inc.
Jun 1, 2017	Venlafaxine Hydrochloride Extended-Release Capsules USP, 75 mg, packaged in a...	Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsu...	Class II	Lucid Pharma LLC
May 22, 2017	Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription P...	Failed Dissolution Specifications: out of specification results observed for low dissolution.	Class II	Dr. Reddy's Laboratories, Inc.
May 22, 2017	Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription P...	Failed Dissolution Specifications: out of specification results observed for low dissolution.	Class II	Dr. Reddy's Laboratories, Inc.
May 22, 2017	Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription P...	Failed Dissolution Specifications: out of specification results observed for low dissolution.	Class II	Dr. Reddy's Laboratories, Inc.
May 22, 2017	Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription P...	Failed Dissolution Specifications: out of specification results observed for low dissolution.	Class II	Dr. Reddy's Laboratories, Inc.
May 18, 2017	Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx on...	Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually ...	Class II	Forest Laboratories, LLC
May 11, 2017	Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American...	GMP Deviations: The firm does not include an SOP for testing for out of specifications.	Class II	AtHome Medical, Inc.
May 10, 2017	Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle ...	Failed Dissolution Specifications	Class II	Zydus Pharmaceuticals USA Inc
May 10, 2017	Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx ...	Failed Dissolution Specifications	Class II	Zydus Pharmaceuticals USA Inc
May 10, 2017	Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC ...	Failed Dissolution Specifications	Class II	Zydus Pharmaceuticals USA Inc
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

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.