Browse Drug Recalls

695 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 695 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 695 FDA drug recalls in PA.

Date	Product	Reason	Class	Firm
Nov 18, 2024	Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV, Rx Only, 60 tablet...	Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st...	Class I	Endo USA, Inc.
Nov 18, 2024	Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (N...	Superpotent Drug and Subpotent Drug: potency failures obtained	Class II	Viatris Inc
Nov 18, 2024	Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (N...	Superpotent Drug and Subpotent Drug: potency failures obtained	Class II	Viatris Inc
Nov 18, 2024	Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (ND...	Superpotent Drug and Subpotent Drug: potency failures obtained	Class II	Viatris Inc
Nov 18, 2024	Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (N...	Superpotent Drug and Subpotent Drug: potency failures obtained	Class II	Viatris Inc
Nov 18, 2024	Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV, Rx Only, 60 ta...	Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st...	Class I	Endo USA, Inc.
Nov 18, 2024	Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (N...	Superpotent Drug and Subpotent Drug: potency failures obtained	Class II	Viatris Inc
Nov 1, 2024	Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in b...	cGMP Deviations	Class II	JR Watkins
Aug 22, 2024	SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded...	Lack of Assurance of Sterility	Class II	ProRx LLC
Aug 22, 2024	TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: P...	Lack of Assurance of Sterility	Class II	ProRx LLC
Aug 22, 2024	TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: P...	Lack of Assurance of Sterility	Class II	ProRx LLC
Aug 22, 2024	SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Com...	Lack of Assurance of Sterility	Class II	ProRx LLC
Aug 22, 2024	Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vi...	Lack of Assurance of Sterility	Class II	ProRx LLC
Aug 22, 2024	Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass ...	Lack of Assurance of Sterility	Class II	ProRx LLC
Aug 22, 2024	Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, C...	Lack of Assurance of Sterility	Class II	ProRx LLC
Jul 10, 2024	Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per ...	Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg ins...	Class I	Endo Pharmaceuticals, Inc.
Jun 26, 2024	Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count...	CGMP Deviations: Out of specification for dissolution	Class II	RemedyRepack Inc.
May 31, 2024	Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: ...	Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbita...	Class II	RemedyRepack Inc.
May 2, 2024	TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3...	Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported findin...	Class II	RemedyRepack Inc.
Apr 30, 2024	Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Onl...	Failed Impurities/Degradation Specifications	Class II	Viatris Inc
Apr 30, 2024	Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Onl...	Failed Impurities/Degradation Specifications	Class II	Viatris Inc
Apr 25, 2024	Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for...	Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing ...	Class III	Viatris Inc
Apr 12, 2024	Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jar...	cGMP Deviations	Class II	Dercher Enterprises, Inc., DBA Gordon Laboratories
Jan 25, 2024	Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent Internat...	CGMP Deviations	Class II	Alpha Aromatics
Nov 22, 2023	TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET...	Chemical Contamination; presence of benzene.	Class I	Insight Pharmaceuticals Corporation
Oct 20, 2023	Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottle...	Failed Viscosity Specifications: Out-of-specification test results for viscosity	Class II	ITF PHARMA INC
Sep 20, 2023	Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech In...	Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP...	Class I	KVK-Tech, 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
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 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 1, 2023	LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn ...	CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product...	Class II	RemedyRepack Inc.
May 1, 2023	Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2...	CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product...	Class II	RemedyRepack Inc.
May 1, 2023	Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, ...	CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product...	Class II	RemedyRepack Inc.
Apr 28, 2023	PHENYLephrine added to 0.9% sodium chloride, 20 mg/250 mL* (80 mcg/mL), 250 m...	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the...	Class II	Central Admixture Pharmacy Services, Inc.
Apr 28, 2023	dilTIAZem added to 0.9% sodium chloride, 125 mg/125 mL* (1 mg/mL), 125 mL per...	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the...	Class II	Central Admixture Pharmacy Services, Inc.
Apr 28, 2023	Modified del Nido Microplegia, packaged in 40 mL per syringe, Rx only, Centra...	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the...	Class II	Central Admixture Pharmacy Services, Inc.
Apr 28, 2023	heparin added to 0.9% sodium chloride, 7,500 units/1,000 mL* (7.5 units/mL), ...	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the...	Class II	Central Admixture Pharmacy Services, Inc.
Apr 28, 2023	oxyTOCIN 60 units added to 0.9% sodium chloride 1,000 mL per bag, Rx only, Ce...	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the...	Class II	Central Admixture Pharmacy Services, Inc.
Apr 28, 2023	Cardioplegia Solution, LEESBURG CARDIOPLEGIA, packaged in 1030.2 mL per bag, ...	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the...	Class II	Central Admixture Pharmacy Services, Inc.
Apr 28, 2023	Neonatal PN Starter Bag, Amino Acids (Trophamine) 3.5%/Dextrose 10% with low ...	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the...	Class II	Central Admixture Pharmacy Services, Inc.
Apr 28, 2023	Cardioplegia Solution, del Nido Formula, packaged in 1,052.8 mL per bag, Rx o...	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the...	Class II	Central Admixture Pharmacy Services, Inc.
Apr 28, 2023	Cardioplegia Solution, Modified St Thomas Solution, low potassium, HIGH SODIU...	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the...	Class II	Central Admixture Pharmacy Services, Inc.
Apr 28, 2023	oxyTOCIN 15 units added to 0.9% sodium chloride 250 mL per bag, Rx only, Cent...	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the...	Class II	Central Admixture Pharmacy Services, Inc.
Apr 28, 2023	tromethamine 0.3 Molar, 50 mL syringe, Rx only, Central Admixture Pharmacy Se...	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the...	Class II	Central Admixture Pharmacy Services, Inc.
Apr 28, 2023	Cardioplegia Solution, Induction 4:1 Plasmalyte, HIGH POTASSIUM, HIGH K, pack...	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the...	Class II	Central Admixture Pharmacy Services, Inc.
Apr 28, 2023	heparin added to 0.9% sodium chloride, 5,000 units/500 mL* (10 units/mL), 500...	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the...	Class II	Central Admixture Pharmacy Services, Inc.
Apr 28, 2023	Cardioplegia Solution, Maintenance 8:1 non-enriched, low potassium, 24 mEq K,...	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the...	Class II	Central Admixture Pharmacy Services, Inc.
Apr 28, 2023	vancomycin added to 0.9% sodium chloride, 1.5 g/500 mL* (3 mg/mL), 500 mL per...	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the...	Class II	Central Admixture Pharmacy Services, Inc.
Apr 28, 2023	Potassium Acetate Injection, 2 mEq/mL, 500 ml bag, Rx only, Central Admixture...	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the...	Class II	Central Admixture Pharmacy Services, Inc.
Apr 28, 2023	PHENYLephrine added to 0.9% sodium chloride, 25 mg/250 mL* (100 mcg/mL), 250 ...	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the...	Class II	Central Admixture Pharmacy Services, 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.