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 7, 2022	Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by:...	Labeling - product contains undeclared ethyl alcohol	Class II	Tsm Brands LLC
Feb 7, 2022	Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx ...	Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufa...	Class II	RISING PHARMACEUTICALS
Feb 7, 2022	Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: ...	Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubrican...	Class II	SUN PHARMACEUTICAL INDUSTRIES INC
Jan 28, 2022	Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles p...	Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for etha...	Class II	AMS Packaging Inc
Jan 28, 2022	Premium Nature Instant Hand Sanitizer, (ethyl alcohol 70%), plastic bottle pa...	Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for etha...	Class II	AMS Packaging Inc
Jan 26, 2022	Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged ...	Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot	Class I	AuroMedics Pharma LLC
Jan 19, 2022	Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Labo...	Failed stability specifications	Class III	Dr. Reddy's Laboratories, Inc.
Jan 19, 2022	Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's ...	Failed stability specifications	Class III	Dr. Reddy's Laboratories, Inc.
Jan 19, 2022	Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's...	Failed stability specifications	Class III	Dr. Reddy's Laboratories, Inc.
Jan 18, 2022	Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 ...	Failed Dissolution Specification: Dissolution results are below specification limits for the acti...	Class II	Teva Pharmaceuticals USA
Jan 14, 2022	Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only...	Failed Impurities/Degradation Specifications	Class II	Aurobindo Pharma USA Inc.
Jan 12, 2022	Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Rx Only, 100 Table...	Failed Dissolution Specifications.	Class II	Ascend Laboratories, LLC
Jan 10, 2022	Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, pack...	Subpotent drug	Class III	Dr. Reddy's Laboratories, Inc.
Jan 10, 2022	Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals US...	Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.	Class II	Teva Pharmaceuticals USA
Jan 7, 2022	Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packag...	Mislabeling	Class III	Teva Pharmaceuticals USA
Jan 7, 2022	Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, package...	Mislabeling	Class III	Teva Pharmaceuticals USA
Jan 4, 2022	Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine...	Failed Dissolution Specifications	Class III	Dr. Reddy's Laboratories, Inc.
Jan 4, 2022	Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedr...	Failed Dissolution Specifications	Class III	Dr. Reddy's Laboratories, Inc.
Jan 4, 2022	Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedr...	Failed Dissolution Specifications	Class III	Dr. Reddy's Laboratories, Inc.
Jan 4, 2022	Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Rele...	Failed Dissolution Specifications	Class III	Dr. Reddy's Laboratories, Inc.
Jan 4, 2022	Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Na...	Failed Dissolution Specifications	Class III	Dr. Reddy's Laboratories, Inc.
Jan 4, 2022	Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudo...	Failed Dissolution Specifications	Class III	Dr. Reddy's Laboratories, Inc.
Jan 4, 2022	equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrin...	Failed Dissolution Specifications	Class III	Dr. Reddy's Laboratories, Inc.
Jan 4, 2022	CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephe...	Failed Dissolution Specifications	Class III	Dr. Reddy's Laboratories, Inc.
Jan 4, 2022	QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Exten...	Failed Dissolution Specifications	Class III	Dr. Reddy's Laboratories, Inc.
Dec 31, 2021	Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose...	Lack of Assurance of Sterility	Class II	Teva Pharmaceuticals USA
Dec 31, 2021	MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 1...	Lack of Assurance of Sterility	Class II	Teva Pharmaceuticals USA
Dec 29, 2021	Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo...	Superpotent and Failed Tablet/Capsule Specifications	Class II	Aurobindo Pharma USA Inc.
Dec 27, 2021	Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE ...	CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da...	Class II	VIONA PHARMACEUTICALS INC
Dec 21, 2021	Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single...	Lack of Assurance of Sterility	Class II	Ideal Specialty Apothecary, Inc. dba Ideal Phar...
Dec 21, 2021	Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem ...	Failed impurities/degradation specifications	Class II	Ascend Laboratories, LLC
Dec 16, 2021	Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) ...	Subpotent	Class II	Teva Pharmaceuticals USA
Dec 8, 2021	Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottl...	Defective Container: The notch in the cap that fits into the nozzle of the dropper could break of...	Class II	Teva Pharmaceuticals USA
Dec 6, 2021	NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint...	MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter...	Class II	Organics Corporation of America DBA Ambix Labor...
Dec 2, 2021	Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufa...	Failed Dissolution Specifications	Class II	Torrent Pharma Inc.
Dec 1, 2021	Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bot...	Superpotent; Hydrochlorothiazide	Class III	Torrent Pharma Inc.
Nov 30, 2021	Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 ...	Superpotent Drug	Class I	Teligent Pharma, Inc.
Nov 30, 2021	Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 ...	Superpotent Drug: Minimally superpotent	Class II	Teligent Pharma, Inc.
Nov 17, 2021	Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Aut...	Temperature Abuse; temperature excursion during shipping	Class I	Sandoz Inc
Nov 15, 2021	Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by...	Failed Impurities/Degradation Specifications	Class III	Aurobindo Pharma USA Inc.
Nov 12, 2021	Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Exten...	Failed dissolution specifications	Class III	Dr. Reddy's Laboratories, Inc.
Nov 12, 2021	Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets U...	Failed dissolution specifications	Class III	Dr. Reddy's Laboratories, Inc.
Nov 12, 2021	Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Exten...	Failed dissolution specifications	Class III	Dr. Reddy's Laboratories, Inc.
Nov 12, 2021	Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoe...	Failed dissolution specifications	Class III	Dr. Reddy's Laboratories, Inc.
Nov 12, 2021	Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablet...	Failed dissolution specifications	Class III	Dr. Reddy's Laboratories, Inc.
Nov 12, 2021	Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Exte...	Failed dissolution specifications	Class III	Dr. Reddy's Laboratories, Inc.
Nov 12, 2021	Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrin...	Failed dissolution specifications	Class III	Dr. Reddy's Laboratories, Inc.
Nov 12, 2021	Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrin...	Failed dissolution specifications	Class III	Dr. Reddy's Laboratories, Inc.
Nov 12, 2021	12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine H...	Failed dissolution specifications	Class III	Dr. Reddy's Laboratories, Inc.
Nov 3, 2021	Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alke...	Failed Impurities/Degradation Specifications	Class II	Ascend 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.