Browse Drug Recalls

1,122 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,122 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 1,122 FDA drug recalls in 2023.

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Date	Product	Reason	Class	Firm
Jul 3, 2023	Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured...	Presence of Particulate Matter: Particulate matter identified as fiber.	Class II	Accord Healthcare, Inc.
Jun 27, 2023	Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net con...	Defective container: empty inhaler and leakage observed through the inhaler valve due to partiall...	Class I	Cipla USA, Inc.
Jun 27, 2023	Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufact...	Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term st...	Class III	Lupin Pharmaceuticals Inc.
Jun 26, 2023	Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 687...	Failed Stability Specifications	Class II	Preferred Pharmaceuticals, Inc.
Jun 26, 2023	Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, ...	Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.	Class II	Strides Pharma Inc.
Jun 23, 2023	Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), pac...	CGMP Deviations: use of non-food grade lubricant in mixing vessel.	Class II	Kramer Laboratories, Inc.
Jun 23, 2023	Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister...	Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. ...	Class II	Amerisource Health Services LLC
Jun 23, 2023	Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppress...	CGMP Deviations: use of non-food grade lubricant in mixing vessel.	Class II	Kramer Laboratories, Inc.
Jun 23, 2023	PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only...	Failed Stability Specifications	Class III	Vivus, Inc.
Jun 23, 2023	Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 m...	Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specific...	Class I	Lupin Pharmaceuticals Inc.
Jun 22, 2023	Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles...	Defective Delivery System	Class II	ALEMBIC PHARMACEUTICALS, INC.
Jun 21, 2023	Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr....	Failed dissolution specification: Out of specification results observed in 24-month long term sta...	Class II	Dr Reddy's Laboratories Limited
Jun 16, 2023	Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx onl...	Packaging defect: blister packaging inadequately sealed.	Class II	The Harvard Drug Group
Jun 13, 2023	Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL O...	CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill l...	Class II	K.C. Pharmaceuticals, Inc
Jun 13, 2023	Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Ma...	Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv...	Class III	AVKARE LLC
Jun 13, 2023	Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polye...	CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill l...	Class II	K.C. Pharmaceuticals, Inc
Jun 12, 2023	Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 va...	cGMP deviations: potential for Microbial Contamination of Non-Sterile Products	Class II	Ferring Pharmaceuticals Inc
Jun 12, 2023	Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only...	Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv...	Class III	Amring Pharmaceuticals Inc
Jun 6, 2023	GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisit...	Labeling: Label Mix-up	Class III	HF Acquisition Co LLC
Jun 5, 2023	Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufa...	cGMP deviations	Class II	Homeocare Laboratories, Inc.
Jun 5, 2023	StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaL...	cGMP deviations	Class II	Homeocare Laboratories, Inc.
Jun 5, 2023	DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Ge...	cGMP deviations	Class II	Homeocare Laboratories, Inc.
Jun 5, 2023	StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distr...	cGMP deviations	Class II	Homeocare Laboratories, Inc.
Jun 5, 2023	StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: Ste...	cGMP deviations	Class II	Homeocare Laboratories, Inc.
Jun 5, 2023	Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distribute...	cGMP deviations	Class II	Homeocare Laboratories, Inc.
Jun 5, 2023	StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed...	cGMP deviations	Class II	Homeocare Laboratories, Inc.
Jun 5, 2023	Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distr...	cGMP deviations	Class II	Homeocare Laboratories, Inc.
Jun 5, 2023	SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99	cGMP deviations	Class II	Homeocare Laboratories, Inc.
Jun 5, 2023	StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distribu...	cGMP deviations	Class II	Homeocare Laboratories, Inc.
Jun 5, 2023	Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New Y...	cGMP deviations	Class II	Homeocare Laboratories, Inc.
May 31, 2023	ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx on...	Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg we...	Class I	The Harvard Drug Group LLC dba Major Pharmaceut...
May 30, 2023	Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun...	Subpotent drug	Class II	SUN PHARMACEUTICAL INDUSTRIES INC
May 30, 2023	Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bo...	Failed Dissolution Specifications: Out-of-specification results for dissolution (above specificat...	Class II	Amneal Pharmaceuticals of New York, LLC
May 25, 2023	Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx onl...	Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container.	Class II	Golden State Medical Supply Inc.
May 25, 2023	Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water...	CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product...	Class II	Viatris Inc
May 23, 2023	Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx onl...	Lack of assurance of sterility: The product was potentially exposed to below-recommended storage ...	Class II	Fresenius Medical Care Holdings, Inc.
May 22, 2023	Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Com...	Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride	Class III	New England Life Care, Inc. dba Advanced Compou...
May 22, 2023	Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged ...	Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for...	Class II	Aurobindo Pharma USA Inc.
May 19, 2023	Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharm...	Lack of Assurance of Sterility	Class II	Sagent Pharmaceuticals Inc
May 19, 2023	Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharm...	Lack of Assurance of Sterility	Class II	Sagent Pharmaceuticals Inc
May 19, 2023	Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd...	Lack of Assurance of Sterility	Class II	Sagent Pharmaceuticals Inc
May 18, 2023	Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by...	Failed Impurities/Degradation Specifications	Class III	Aurolife Pharma, LLC
May 16, 2023	FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters...	CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specificatio...	Class II	Alpha Aromatics
May 15, 2023	Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only,...	Lack of Assurance of Sterility	Class II	Astral SteriTech Private Ltd.
May 15, 2023	Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, Rx only,...	Lack of Assurance of Sterility	Class II	Astral SteriTech Private Ltd.
May 15, 2023	Cefepime for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Crit...	Lack of Assurance of Sterility	Class II	Astral SteriTech Private Ltd.
May 15, 2023	Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Manufa...	Lack of Assurance of Sterility	Class II	Astral SteriTech Private Ltd.
May 15, 2023	Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: ...	Lack of Assurance of Sterility	Class II	Astral SteriTech Private Ltd.
May 15, 2023	Ampicillin for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Cri...	Lack of Assurance of Sterility	Class II	Astral SteriTech Private Ltd.
May 15, 2023	Ceftriaxone for Injection, USP, 2 grams per vial, Rx only, Manufactured for: ...	Lack of Assurance of Sterility	Class II	Astral SteriTech Private Ltd.

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.