Browse Drug Recalls

2,002 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,002 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 2,002 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Nov 9, 2022	Timolol-Latanoprost (0.5/0.005%) ophthalmic drops, Compounded, 5 mL bottle, I...	Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.	Class II	ImprimisRx NJ
Oct 18, 2022	Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton contain...	Defective Delivery System: Commercial implants do not meet the filed specification for the intend...	Class III	Genentech Inc
Oct 11, 2022	NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN ...	Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg	Class III	LNK International, Inc.
Sep 29, 2022	Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: AL...	Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets	Class I	Golden State Medical Supply Inc.
Aug 30, 2022	Antibacterial Foaming Wash with Hydria Moisturizing Formula, Cucumber-Melon S...	Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label.	Class III	Woodbine Products Co Inc
Aug 29, 2022	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat...	Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually...	Class II	Teva Pharmaceuticals USA Inc
Aug 4, 2022	Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container b...	Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets ind...	Class II	Baxter Healthcare Corporation
Aug 4, 2022	Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blist...	Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate...	Class III	LNK International, Inc.
Jul 20, 2022	Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured fo...	Labeling: Label Error on Declared Strength	Class III	AVKARE Inc.
Jul 19, 2022	Luxury 70% Isopropyl Alcohol, First Aid Antiseptic with Wintergreem12 FL. OZ....	Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol	Class II	Tsm Brands LLC
Jul 19, 2022	Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1 PT) 473 ML, Distributed by: TSM B...	Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol	Class II	Tsm Brands LLC
Jul 15, 2022	Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.74...	Microbial contamination of non-sterile products.	Class I	Vi-Jon, LLC
Jul 15, 2022	Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Cherry Flavor, 10 ...	CGMP Deviations	Class II	Vi-Jon, LLC
Jul 15, 2022	Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Grape Flavor, 10 F...	CGMP Deviations;	Class II	Vi-Jon, LLC
Jul 15, 2022	Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.74...	Microbial contamination of non-sterile products.	Class I	Vi-Jon, LLC
Jul 8, 2022	Crest 3D White Fluoride Anticavity Toothpaste, Advanced Triple Whitening, 0.2...	Labeling: Missing label: the product tube was missing a label and contained a different formulation.	Class III	The Procter & Gamble Company
Jul 5, 2022	Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 m...	Labeling: Missing label: Label missing from some prefilled pens.	Class I	Mylan Pharmaceuticals Inc
Jun 29, 2022	Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manuf...	CGMP Deviations: products were stored outside the drug label specifications.	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022	A&D Original Ointment, Diaper Rash Ointment & Skin Protectant, 16 oz. Jar, Ba...	CGMP Deviations: products were stored outside the drug label specifications.	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022	Debrox, Carbamide Peroxide, Earwax Removal Aid, 0.5 FL OZ (15 mL) bottle per ...	CGMP Deviations: products were stored outside the drug label specifications.	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022	Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restor...	CGMP Deviations: products were stored outside the drug label specifications.	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022	Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propyle...	CGMP Deviations: products were stored outside the drug label specifications.	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022	Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories pe...	CGMP Deviations: products were stored outside the drug label specifications.	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022	Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Red...	CGMP Deviations: products were stored outside the drug label specifications.	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022	Triple Antibiotic Ointment, Bacitracin zinc, Neomycin sulfate, Polymixin B su...	CGMP Deviations: products were stored outside the drug label specifications.	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022	Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alco...	CGMP Deviations: products were stored outside the drug label specifications.	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022	Alcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box, M...	CGMP Deviations: products were stored outside the drug label specifications.	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022	Dakin's Solution, a) sodium hypochlorite 0.125%, quarter strength, NDC 0436-0...	CGMP Deviations: products were stored outside the drug label specifications.	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022	Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporar...	CGMP Deviations: products were stored outside the drug label specifications.	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022	GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (...	CGMP Deviations: products were stored outside the drug label specifications.	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022	Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhal...	CGMP Deviations: products were stored outside the drug label specifications.	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022	Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30...	CGMP Deviations: products were stored outside the drug label specifications.	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022	Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2...	CGMP Deviations: products were stored outside the drug label specifications.	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Jun 29, 2022	Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine...	CGMP Deviations: products were stored outside the drug label specifications.	Class II	Mckesson Medical-Surgical Inc. Corporate Office
Jun 27, 2022	Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code ...	Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.	Class II	Loud Muscle Science
Jun 27, 2022	Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPW...	Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.	Class II	Loud Muscle Science
Jun 27, 2022	Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code ...	Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.	Class II	Loud Muscle Science
Jun 24, 2022	Hydrogen Peroxide Topical Solution, USP, 32 fl. oz. (1 QT) 946 mL, Distribute...	Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affix...	Class II	Vi-Jon, LLC
Jun 17, 2022	Morphine Sulfate extended-Release Tablets, USP; 30 mg, 100-count bottles, Rx ...	Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets conta...	Class I	Bryant Ranch Prepack, Inc.
Jun 17, 2022	Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx ...	Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets conta...	Class I	Bryant Ranch Prepack, Inc.
May 24, 2022	Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, a) 100-count bottl...	Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labe...	Class II	Walmart Inc
May 24, 2022	Artri Ajo King Reforzado con Ortiga y Omega 3 Tablets, ORIGINAL, 100-count bo...	Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labe...	Class II	Walmart Inc
May 23, 2022	Tegsedi (inotersen) Injection 284 mg/1.5 mL, Rx Only, Sterile solution for Su...	Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).	Class I	Akcea Therapeutics, Inc.
May 17, 2022	AMBI Skincare Fade Cream Normal Skin, Net Wt. 2 OZ. (56g)	cGMP deviations: product stored outside of labeled temperature requirements.	Class II	Family Dollar Stores, Llc.
May 17, 2022	AMBI Skincare Even & Clear Exfoliating Wash Salicylic Acid Acne Treatment Wit...	cGMP deviations: product stored outside of labeled temperature requirements.	Class II	Family Dollar Stores, Llc.
May 17, 2022	Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E, 8 FL. OZ. ...	cGMP deviations: product stored outside of labeled temperature requirements.	Class II	Family Dollar Stores, Llc.
May 17, 2022	Aveeno Daily Moisturizing lotion Fragrance Free with Soothing Oat & Rich Emol...	cGMP deviations: product stored outside of labeled temperature requirements.	Class II	Family Dollar Stores, Llc.
May 17, 2022	Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E Advanced Al...	cGMP deviations: product stored outside of labeled temperature requirements.	Class II	Family Dollar Stores, Llc.
May 17, 2022	Only At Family Dollar AMBI Skincare Even & Clear Nourishing Daily Facial Mois...	cGMP deviations: product stored outside of labeled temperature requirements.	Class II	Family Dollar Stores, Llc.
May 17, 2022	AMBI Skincare Fade Cream Oily Skin New & Improved, Net Wt. 2 OZ (56g)	cGMP deviations: product stored outside of labeled temperature requirements.	Class II	Family Dollar Stores, 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.