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.

Clear

Date	Product	Reason	Class	Firm
Jul 19, 2021	Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma...	Correct Labeled Product Mispack	Class II	Teligent Pharma, Inc.
Jul 19, 2021	Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Red...	Failed Tablet/Capsule Specification: Some tablets are shaved	Class II	Dr. Reddy's Laboratories, Inc.
Jul 19, 2021	Triamcinolone Acetonide Ointment USP, 0.1% 80 g cartons, Rx Only, Teligent P...	Correct Labeled Product Mispack	Class II	Teligent Pharma, Inc.
Jul 14, 2021	Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ...	Chemical Contamination: presence of benzene	Class I	Johnson & Johnson Consumer, Inc.
Jul 14, 2021	Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ...	cGMP Deviations	Class II	Johnson & Johnson Consumer, Inc.
Jul 14, 2021	Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3...	cGMP Deviations	Class II	Johnson & Johnson Consumer, Inc.
Jul 14, 2021	Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (...	cGMP Deviations	Class II	Johnson & Johnson Consumer, Inc.
Jul 14, 2021	Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 100+, Avobenzon...	cGMP Deviations	Class II	Johnson & Johnson Consumer, Inc.
Jul 14, 2021	Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone ...	cGMP Deviations	Class II	Johnson & Johnson Consumer, Inc.
Jul 14, 2021	Aveeno Protect + Refresh sunscreen weightless spray with oat SPF 60, Avobenzo...	cGMP Deviations	Class II	Johnson & Johnson Consumer, Inc.
Jul 14, 2021	Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ...	Chemical Contamination: presence of benzene	Class I	Johnson & Johnson Consumer, Inc.
Jul 14, 2021	Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ...	cGMP Deviations	Class II	Johnson & Johnson Consumer, Inc.
Jul 14, 2021	Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ...	cGMP Deviations	Class II	Johnson & Johnson Consumer, Inc.
Jul 14, 2021	Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 45, Avobenzone ...	cGMP Deviations	Class II	Johnson & Johnson Consumer, Inc.
Jul 14, 2021	Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 70, Avobenzone...	cGMP Deviations	Class II	Johnson & Johnson Consumer, Inc.
Jul 14, 2021	Neutrogena COOLDRY SPORT sunscreen spray SPF 30, Avobenzone (3%), Homosalate ...	cGMP Deviations	Class II	Johnson & Johnson Consumer, Inc.
Jul 14, 2021	Neutrogena COOLDRY SPORT WITH MICROMESH SUNSCREEN SPRAY Broad Spectrum SPF 50...	cGMP Deviations	Class II	Johnson & Johnson Consumer, Inc.
Jul 14, 2021	Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ...	cGMP Deviations	Class II	Johnson & Johnson Consumer, Inc.
Jul 14, 2021	Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3...	cGMP Deviations	Class II	Johnson & Johnson Consumer, Inc.
Jul 14, 2021	Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone...	cGMP Deviations	Class II	Johnson & Johnson Consumer, Inc.
Jul 14, 2021	Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ...	cGMP Deviations	Class II	Johnson & Johnson Consumer, Inc.
Jul 14, 2021	Neutrogena Beach Defense water + sun protection sunscreen spray BROAD SPECTRU...	cGMP Deviations	Class II	Johnson & Johnson Consumer, Inc.
Jul 14, 2021	Neutrogena Invisible Daily defense body spray sunscreen BROAD SPECTRUM SPF 60...	cGMP Deviations	Class II	Johnson & Johnson Consumer, Inc.
Jul 7, 2021	Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, ...	Presence of Foreign Substance- Potential of metal contamination.	Class II	Aurobindo Pharma USA Inc.
Jun 22, 2021	Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., ...	Failed Impurities/Degradation Specifications	Class III	Teligent Pharma, Inc.
Jun 22, 2021	Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(N...	Failed Impurities/Degradation Specifications	Class III	Teligent Pharma, Inc.
Jun 18, 2021	Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceutical...	Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. ...	Class I	Teva Pharmaceuticals USA
Jun 10, 2021	Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured...	CGMP Deviations	Class II	CIPLA
Jun 8, 2021	Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Ocean...	Failed Impurities/Degradation Specifications	Class III	Bausch Health Companies, Inc.
Jun 8, 2021	Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufacture...	Failed Impurities/Degradation Specifications	Class III	Bausch Health Companies, Inc.
Jun 4, 2021	Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Redd...	Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities	Class III	Dr. Reddy's Laboratories, Inc.
Jun 1, 2021	Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx...	CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da...	Class II	VIONA PHARMACEUTICALS INC
May 14, 2021	Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-...	Presence of Foreign Substance: Foreign particles observed during routine stability testing.	Class II	Teligent Pharma, Inc.
May 7, 2021	Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouche...	Subpotent and Presence of Particulates .	Class III	SUN PHARMACEUTICAL INDUSTRIES INC
May 4, 2021	Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bo...	Presence of foreign substance: identified as activated carbon.	Class II	SUN PHARMACEUTICAL INDUSTRIES INC
May 4, 2021	Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: ...	Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities	Class III	Dr. Reddy's Laboratories, Inc.
Apr 29, 2021	Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured b...	Presence of Foreign Tablet/Capsule	Class III	Ascend Laboratories LLC
Apr 26, 2021	Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multipl...	Lack of Assurance of Sterility	Class II	Teva Pharmaceuticals USA
Apr 26, 2021	Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx On...	Lack of Assurance of Sterility	Class II	Teva Pharmaceuticals USA
Apr 26, 2021	Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx ...	Lack of Assurance of Sterility	Class II	Teva Pharmaceuticals USA
Apr 26, 2021	Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg...	Lack of Assurance of Sterility	Class II	Teva Pharmaceuticals USA
Apr 26, 2021	Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Onl...	Lack of Assurance of Sterility	Class II	Teva Pharmaceuticals USA
Apr 21, 2021	Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Ph...	Labeling: Incorrect or Missing Lot and/or Exp Date	Class III	Heritage Pharmaceuticals Inc
Apr 9, 2021	Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pha...	Failed Impurities/Degradation Specifications:	Class II	Teligent Pharma, Inc.
Apr 6, 2021	PremierZen Extreme 3000, packaged in cardboard blisters containing one caps...	Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.	Class II	Hyobin LLC
Apr 6, 2021	Triple SupremeZen Plus 3500, packaged in cardboard blisters containing one ...	Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.	Class II	Hyobin LLC
Apr 6, 2021	PremierZen Black 5000, packaged in cardboard blisters containing one capsul...	Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.	Class II	Hyobin LLC
Mar 31, 2021	Burro en Primavera, 2 capsules, UPC 638632431055	Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/o...	Class II	QMart
Mar 31, 2021	Imperial Platinum 2000, 1 capsule, UPC 718122040702	Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/o...	Class II	QMart
Mar 31, 2021	PremierZen Extreme 3000, Male Sexual Performance Enhancement, 1 Capsule, UPC ...	Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/o...	Class II	QMart

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.