Browse Drug Recalls

3,430 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,430 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 3,430 FDA drug recalls.

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DateProductReasonClassFirm
Nov 2, 2018 IRBESARTAN Tablets, USP 300 mg (a) 30-count bottle (NDC 60429-642-30), (b) 90... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine ... Class II Golden State Medical Supply Inc.
Nov 2, 2018 IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine ... Class II Golden State Medical Supply Inc.
Nov 2, 2018 IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciG... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine ... Class II Golden State Medical Supply Inc.
Nov 1, 2018 Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, ... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... Class II Sandoz, Inc
Oct 29, 2018 Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-11... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Sciegen Pharmaceuticals Inc
Oct 29, 2018 GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30),... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Sciegen Pharmaceuticals Inc
Oct 29, 2018 Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Sciegen Pharmaceuticals Inc
Oct 29, 2018 GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured b... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Sciegen Pharmaceuticals Inc
Oct 29, 2018 Westminster Irbesartan Tablets, USP 75 mg Rx Only Manufactured by: ScieGen Ph... CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Ir... Class II Westminster Pharmaceuticals Llc
Oct 29, 2018 GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), ... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Sciegen Pharmaceuticals Inc
Oct 29, 2018 Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen P... CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Ir... Class II Westminster Pharmaceuticals Llc
Oct 29, 2018 Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC... CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine... Class II Sciegen Pharmaceuticals Inc
Oct 29, 2018 Westminster Irbesartan Tablets, USP 150 mg Rx Only Manufactured by: ScieGen P... CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Ir... Class II Westminster Pharmaceuticals Llc
Oct 26, 2018 Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8... CGMP Deviations: Product was released to market prior to microbiological testing. Class II S.C. Johnson Professional
Oct 26, 2018 deb stoko, Refresh AntiBac FOAM (benzalkonium chloride), 0.13%, 1 L (33.8 fl.... CGMP Deviations: Product was released to market prior to microbiological testing. Class II S.C. Johnson Professional
Oct 24, 2018 Irbesartan Bulk Active Pharmaceutical Ingredient. CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the... Class II Aurobindo Pharma Limited (Unit I)
Oct 11, 2018 HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP... CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for... Class II Lannett Company, Inc.
Oct 9, 2018 AllergEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spra... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 DigestivEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Diet Power, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Spra... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 MenoPower, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spray... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Woman Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spr... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Body Skin Tonic, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Acne Tonic Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Spray... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Party Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Stress Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for S... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 TravelEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spra... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Cold + Flu Relief, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured f... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Rejuvenation Plus, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured f... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Life Detoxer Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Spr... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Brain Power,Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spra... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 SleepEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spray... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Snore Soother, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for S... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Body Balance, Homeopathic Oral Spray 1.38 fl. oz (41 mL). Manufactured by Spr... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 PMS Support, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spr... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 ImmunoBooster, Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by S... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Man Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Spray... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Arnica Power, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 9, 2018 Bone Builder, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sp... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Sprayology
Oct 3, 2018 Healthful Naturals DizziFree Oral Spray, 2 fl oz (59 mL) per bottle, Distribu... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Silver Star Brands
Oct 3, 2018 Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, ... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Silver Star Brands
Sep 26, 2018 Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per... CGMP deviations Class II GLAXOSMITHKLINE NEBRASKA
Sep 20, 2018 Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx ... CGMP Deviations; rejected product was used to manufacture final bulk lot Class II Pfizer Inc.
Sep 6, 2018 0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare ... cGMP Deviation Class II Baxter Healthcare Corporation
Aug 31, 2018 NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, package... CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, ... Class II BioLyte Laboratories, LLC
Aug 31, 2018 Skin Irritation & Itch Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per ... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Beaumont Bio-med, Inc.
Aug 31, 2018 Diarrhea Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass or... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Beaumont Bio-med, Inc.
Aug 31, 2018 Allergy & Hay Fever Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Beaumont Bio-med, Inc.
Aug 31, 2018 Sinus Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral ... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Beaumont Bio-med, Inc.
Aug 31, 2018 Colds & Flu Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Beaumont Bio-med, 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.