Browse Drug Recalls

3,458 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,458 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 3,458 FDA drug recalls.

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DateProductReasonClassFirm
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.
Aug 31, 2018 Arthritis Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glas... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Beaumont Bio-med, Inc.
Aug 31, 2018 Muscle & Joint Pain 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 Sore Throat & Laryngitis Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) pe... CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... Class II Beaumont Bio-med, Inc.
Aug 30, 2018 Thyroid powder, 4.5 kg foil bag, 5x1 kg foil bags packed in 25 Kg Fiber Drum,... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Alkano Chemicals, Inc
Aug 28, 2018 Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grai... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Humco Holding Group, Inc
Aug 28, 2018 Thyroid, USP (Full Strength) Levothyroxine 112.1 mcg/grain Liothyronine 29.2 ... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Humco Holding Group, Inc
Aug 28, 2018 Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grai... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Humco Holding Group, Inc
Aug 24, 2018 Thyroid Powder, USP, 25kg/drum, Rx Only, Sichuan Friendly Pharmaceutical Co.,... CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine a... Class II LGM Pharma LLC
Aug 24, 2018 Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) ... CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products ... Class II Valeant Pharmaceuticals North America LLC
Aug 24, 2018 Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Di... CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products ... Class II Valeant Pharmaceuticals North America LLC
Aug 24, 2018 Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in c... CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an act... Class II RemedyRepack Inc.
Aug 24, 2018 Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. ... CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products ... Class II Valeant Pharmaceuticals North America LLC
Aug 22, 2018 THYROID POWDER USP (Levothyroxine labeled range of 34.2-41.8mcg/grain; Liothy... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Syntec Pharma Corp
Aug 22, 2018 THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/... CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... Class II Syntec Pharma Corp
Aug 21, 2018 0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Co... CGMP Deviations Class II Baxter Healthcare Corporation
Aug 21, 2018 Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical C... CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine... Class II Sichuan Friendly Pharmaceutical Co.,Ltd.
Aug 20, 2018 Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles ... CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an act... Class II RemedyRepack Inc.
Aug 17, 2018 Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Torrent Pharma Inc.
Aug 17, 2018 Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Torrent Pharma Inc.
Aug 17, 2018 Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, R... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Torrent Pharma Inc.
Aug 17, 2018 Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Torrent Pharma Inc.
Aug 17, 2018 Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 ... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Torrent Pharma 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.