Browse Drug Recalls

2,097 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,097 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 2,097 FDA drug recalls in NJ.

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Date	Product	Reason	Class	Firm
Feb 10, 2021	MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL),...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 1X10ML vial, Rx...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL Multiple-do...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-D...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL,...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), pa...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC ...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 10, 2021	Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial, Rx...	Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance...	Class II	Teva Pharmaceuticals USA
Feb 5, 2021	Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distribute...	Failed Impurity/Degradation Specifications	Class III	SUN PHARMACEUTICAL INDUSTRIES INC
Feb 2, 2021	Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 gr...	Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.	Class III	Teligent Pharma, Inc.
Feb 2, 2021	Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 gr...	Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.	Class III	Teligent Pharma, Inc.
Feb 2, 2021	Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 g...	Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.	Class III	Teligent Pharma, Inc.
Jan 22, 2021	Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx On...	CGMP Deviations: Individual Unidentified impurities results of the product was found at higher si...	Class II	Ascend Laboratories LLC
Jan 22, 2021	Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx O...	CGMP Deviations: Individual Unidentified impurities results of the product was found at higher si...	Class II	Ascend Laboratories LLC
Jan 20, 2021	Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Au...	Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a...	Class II	Aurobindo Pharma USA Inc.
Jan 11, 2021	Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONL...	Incorrect Labeling: Incorrect lot number on secondary packaging	Class III	SUN PHARMACEUTICAL INDUSTRIES INC
Jan 7, 2021	Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured ...	Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability t...	Class III	Bausch Health Companies, Inc.
Jan 7, 2021	Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceansi...	Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability t...	Class III	Bausch Health Companies, Inc.
Dec 30, 2020	Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vi...	Discoloration and failed pH specifications	Class II	AuroMedics Pharma LLC
Dec 30, 2020	Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) S...	Labeling: Missing instructions for use insert	Class II	Allergan, PLC.
Dec 22, 2020	NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactur...	Failed Moisture Limits	Class III	Strides Pharma Inc.
Dec 21, 2020	Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose...	Lack of assurance of sterility: The results of sterility tests of seven batches of product were o...	Class II	Merck Sharp & Dohme
Dec 17, 2020	Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in ...	Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with th...	Class II	CIPLA
Dec 17, 2020	Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL ...	Failed Impurity/Degradation Specifications	Class II	Ascend Laboratories LLC
Dec 17, 2020	Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL ...	Failed Impurity/Degradation Specifications	Class II	Ascend Laboratories LLC
Dec 17, 2020	Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in ...	Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with th...	Class II	CIPLA
Dec 17, 2020	Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in ...	Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with th...	Class II	CIPLA
Dec 17, 2020	Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1m...	Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.	Class II	Imprimis NJOF, LLC
Dec 14, 2020	Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use On...	cGMP deviations: Vials may not be sealed correctly affecting sterility.	Class II	CIPLA
Dec 7, 2020	Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/ml, 2mL Single Dose Vial, ...	Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Inje...	Class II	Hikma Pharmaceuticals USA Inc.
Dec 3, 2020	Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 100 Tablet...	Failed Dissolution Specifications	Class II	Zydus Pharmaceuticals (USA) Inc
Dec 3, 2020	Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100 Tablets...	Failed Dissolution Specifications	Class II	Zydus Pharmaceuticals (USA) Inc
Nov 24, 2020	Tizanidine Tablets, USP 4mg, Rx Only, 150 Tablets per Bottle, Manufactured by...	Failed Dissolution Specifications; Out of Specification (low) results were obtained.	Class II	Ascend Laboratories LLC
Nov 23, 2020	Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (...	Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specificat...	Class II	Ascend Laboratories LLC
Nov 19, 2020	CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Di...	Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment.	Class II	US Pharmaceuticals Inc.
Nov 17, 2020	Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in...	Cross contamination: the excipient was found to be contaminated with theophylline.	Class II	BASF Corporation
Nov 11, 2020	Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, ...	Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5...	Class III	InvaTech Pharma Solutions, LLC
Nov 11, 2020	Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose ...	Superpotent Drug: High out-of-specification assay results were obtained during stability testing.	Class III	Teva Pharmaceuticals USA
Nov 10, 2020	Levetiracetam Tablets, USP 500 mg, packaged in 120-count bottle, Rx only, Man...	Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle o...	Class II	EYWA PHARMA INC
Nov 5, 2020	Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent...	Superpotent and Subpotent; low and high assay results	Class III	Teligent Pharma, Inc.
Nov 3, 2020	Sodium Chloride Injection, USP, 0.9%, 0.308 mOsmol/mL, 2mL Single Dose Vial, ...	Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Inje...	Class II	Hikma Pharmaceuticals USA Inc.
Nov 3, 2020	Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only,...	Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.	Class III	Teligent Pharma, Inc.
Oct 28, 2020	Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx ...	Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during ...	Class II	Teva Pharmaceuticals USA
Oct 27, 2020	Lansoprazole Delayed-Release Orally Disintegrating Tablets 30 mg, 100-count c...	Failed Dissolution Specification	Class II	Zydus Pharmaceuticals (USA) Inc
Oct 27, 2020	Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg, 100-count c...	Failed Dissolution Specification	Class II	Zydus Pharmaceuticals (USA) Inc
Oct 23, 2020	Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Dis...	Failed impurities/ degradation specifications: Out of specification impurity results were observe...	Class III	Heritage Pharmaceuticals Inc
Oct 22, 2020	Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL ...	Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.	Class III	Aurobindo Pharma USA 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.