Browse Drug Recalls

1,392 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,392 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 1,392 FDA drug recalls in 2022.

Date	Product	Reason	Class	Firm
Dec 22, 2022	Acetylcysteine 10% Ophthalmic Solution, Rx Only, Pharmacy Innovations, 2936 W...	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Class II	Pharmacy Innovations
Dec 22, 2022	TOBRAMYCIN FORTIFIED 15MG/ML OPH SOLUTION, Rx Only, Pharmacy Innovations, 293...	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Class II	Pharmacy Innovations
Dec 22, 2022	Atropine sulfate 0.05%, 1ML dropper, and Atropine sulfate 0.01%, 1 ML dropper...	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Class II	Pharmacy Innovations
Dec 22, 2022	METHION/INOSIT/CHOLINE/CYANOCOBAL 25MG/50MG/50MG/1MG/ML (1ML VIAL) INJECTABLE...	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Class II	Pharmacy Innovations
Dec 22, 2022	GLUTATHIONE L REDUCED 100MG/ML (2ML NEBVL) INHALATION; GLUTATHIONE L REDUCED ...	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Class II	Pharmacy Innovations
Dec 21, 2022	Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apote...	Failed Stability Specifications: Out of specification for weight loss at the 18-month stability t...	Class III	Apotex Corp.
Dec 20, 2022	Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Di...	Failed Impurities/Degradations Specifications	Class II	Amerisource Health Services LLC
Dec 20, 2022	Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma,...	Failed Impurities/Degradation specifications	Class II	RemedyRepack Inc.
Dec 19, 2022	Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles...	Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could ...	Class I	Spectrum Laboratory Products, Inc.
Dec 19, 2022	Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a va...	Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could ...	Class I	Spectrum Laboratory Products, Inc.
Dec 16, 2022	Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton...	Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-coun...	Class II	Hikma Pharmaceuticals USA Inc.
Dec 16, 2022	Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Auro...	Failed Impurities/Degradation Specifications	Class II	Aurolife Pharma, LLC
Dec 15, 2022	Easy Clean 75% Ethyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 918...	cGMP Deviations	Class II	Frenda Corporation
Dec 15, 2022	Easy Clean Isopropyl Alcohol 99%, 1 Gallon (128 fl. oz.), Manufactured by: Fr...	cGMP Deviations	Class II	Frenda Corporation
Dec 15, 2022	Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original, 1 Gall...	cGMP Deviations	Class II	Frenda Corporation
Dec 15, 2022	Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (1...	cGMP Deviations	Class II	Frenda Corporation
Dec 15, 2022	Easy Clean 70% Isopropyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8...	cGMP Deviations	Class II	Frenda Corporation
Dec 15, 2022	Global Care 70% Alcohol Ethyl Rubbing Alcohol, packaged in a) 32 FL OZ (946 m...	cGMP Deviations	Class II	Frenda Corporation
Dec 15, 2022	Easy Clean Alcohol Mult Surface Disinfecting Cleaner 75% Ethyl Alcohol, 32 FL...	cGMP Deviations	Class II	Frenda Corporation
Dec 12, 2022	Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g)...	cGMP Deviations	Class II	Atlantic Management Resources Ltd.
Dec 12, 2022	Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lu...	Failed Impurities/Degradation Specifications: Failure observed in related substance testing durin...	Class II	Lupin Pharmaceuticals Inc.
Dec 12, 2022	Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g...	cGMP Deviations	Class II	Atlantic Management Resources Ltd.
Dec 12, 2022	Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged...	cGMP Deviations	Class II	Atlantic Management Resources Ltd.
Dec 12, 2022	ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 ...	cGMP Deviations	Class II	Atlantic Management Resources Ltd.
Dec 9, 2022	Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution,...	CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess o...	Class II	NCH Life Sciences LLC
Dec 8, 2022	Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/...	Presence of Particulate Matter: Presence of foreign substances were reported in vials at the phar...	Class II	McGuff Compounding Pharmacy Services, Inc.
Dec 8, 2022	Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) In...	Presence of Particulate Matter: Presence of foreign substances were reported in vials at the phar...	Class II	McGuff Compounding Pharmacy Services, Inc.
Dec 7, 2022	Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Phar...	CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.	Class II	Lupin Pharmaceuticals Inc.
Dec 7, 2022	Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Phar...	CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.	Class II	Lupin Pharmaceuticals Inc.
Dec 6, 2022	Advil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 05...	Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear ...	Class I	Glaxosmithkline Consumer Healthcare Holdings DB...
Dec 6, 2022	Advil Liqui Gels, Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever ...	Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear ...	Class I	Glaxosmithkline Consumer Healthcare Holdings DB...
Dec 6, 2022	Advil Liqui Gels (minis), Solubilized ibuprofen capsules, 200mg, Pain Relieve...	Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear ...	Class I	Glaxosmithkline Consumer Healthcare Holdings DB...
Dec 6, 2022	Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Onl...	Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid c...	Class III	Camber Pharmaceuticals, Inc
Dec 5, 2022	Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 2315...	Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.	Class II	RemedyRepack Inc.
Dec 2, 2022	TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewabl...	Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.	Class II	GlaxoSmithKline Consumer Healthcare Holdings LLC
Dec 2, 2022	TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewabl...	Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.	Class II	GlaxoSmithKline Consumer Healthcare Holdings LLC
Dec 2, 2022	TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable ...	Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.	Class II	GlaxoSmithKline Consumer Healthcare Holdings LLC
Dec 2, 2022	TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tabl...	Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.	Class II	GlaxoSmithKline Consumer Healthcare Holdings LLC
Dec 2, 2022	TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewabl...	Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.	Class II	GlaxoSmithKline Consumer Healthcare Holdings LLC
Dec 2, 2022	TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tabl...	Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.	Class II	GlaxoSmithKline Consumer Healthcare Holdings LLC
Dec 2, 2022	TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewabl...	Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.	Class II	GlaxoSmithKline Consumer Healthcare Holdings LLC
Dec 1, 2022	Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syr...	Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained pro...	Class I	BayCare Integrated Service Center, LLC /dba Bay...
Dec 1, 2022	Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185...	Presence of foreign substance	Class II	SUN PHARMACEUTICAL INDUSTRIES INC
Nov 29, 2022	FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Fre...	Underfilled units.	Class II	OurPharma LLC
Nov 29, 2022	Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufacture...	Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomyc...	Class I	Accord Healthcare, Inc.
Nov 28, 2022	8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single D...	Defective Container: Complaints received of vial breakage and glass flying when pressurized while...	Class I	Exela Pharma Sciences LLC
Nov 28, 2022	8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single D...	Defective Container: Complaints received of vial breakage and glass flying when pressurized while...	Class I	Exela Pharma Sciences LLC
Nov 25, 2022	0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC ...	Lack of sterility assurance: Bags have the potential to leak.	Class II	B. Braun Medical, Inc.
Nov 23, 2022	Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed b...	Subpotent Drug	Class II	Heritage Pharmaceuticals Inc
Nov 22, 2022	Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine...	Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.	Class II	Fresenius Kabi USA, 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.