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
Apr 20, 2016	FARSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The People...	Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ...	Class II	Murray International Trading Co., Inc.
Apr 20, 2016	FUCONPO CAPSULE, packaged in a 30-count bottle within a box, remaining labeli...	Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ...	Class II	Murray International Trading Co., Inc.
Apr 20, 2016	FUQINGSONG RELIEF CREAM (Flucinonide Ointment), packaged in 50-count individu...	Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ...	Class II	Murray International Trading Co., Inc.
Apr 20, 2016	GASTRODIA CAPSULES, packaged in 30-count bottles within a box, LANZHOU MANUFA...	Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ...	Class II	Murray International Trading Co., Inc.
Apr 20, 2016	CROCODILE BILE PILL FOR ASTHMA, packaged in 100-count bottles within a box, r...	Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ...	Class II	Murray International Trading Co., Inc.
Apr 20, 2016	Tien Ma Tou Tong Wan (Condensed pills), packaged in 100-count bottles within ...	Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ...	Class II	Murray International Trading Co., Inc.
Apr 20, 2016	PEKING NIU-HUANG CHIEH-TU-PIEN Tablets (Sugar Coated), packaged in 50-count b...	Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ...	Class II	Murray International Trading Co., Inc.
Apr 20, 2016	PATCH-REMOUING PILL (For Facial Pigmentation), packaged in a bottle within a ...	Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ...	Class II	Murray International Trading Co., Inc.
Apr 20, 2016	ChingChunBao ANTI-AGING TABLETS, packaged in 80-count bottles within a box, U...	Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ...	Class II	Murray International Trading Co., Inc.
Apr 20, 2016	LARYNGITIS PILLS Herbal Supplement, packaged in 10-count packets containing 3...	Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ...	Class II	Murray International Trading Co., Inc.
Apr 20, 2016	WUPOOSER KAI YEUNG PILL, packaged in a bottle within a box, Made in The Peopl...	Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ...	Class II	Murray International Trading Co., Inc.
Apr 20, 2016	PING ON OINTMENT RELIEF FOR MUSCULAR PAIN, packaged in a packet of 12-count 8...	Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ...	Class II	Murray International Trading Co., Inc.
Apr 20, 2016	Te Xiao BaiNeiTing Herbal Supplement (Naphazoline HCl Solution 0.1%) liquid, ...	Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ...	Class II	Murray International Trading Co., Inc.
Apr 20, 2016	SCIATICA PILLS, packaged in 120-count bottles within a box, Made in the Peopl...	Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ...	Class II	Murray International Trading Co., Inc.
Apr 12, 2016	SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC...	Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.	Class III	Mckesson Packaging Services
Apr 7, 2016	Good Neighbor Pharmacy PEG-Phen Lubricant Eye Drops (Polyethylene Glycol 400 ...	Presence of Particulate Matter	Class II	Akorn, Inc.
Apr 5, 2016	Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intraven...	Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Pres...	Class II	Fresenius Kabi USA, LLC
Mar 31, 2016	Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Bliste...	Labeling: Incorrect or Missing Lot and/or Exp Date	Class III	Amerisource Health Services
Mar 31, 2016	Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs ...	Labeling: Incorrect or Missing Lot and/or Exp Date	Class III	Amerisource Health Services
Mar 30, 2016	PHENYLephrine 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL syringe,...	Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case...	Class I	QuVa Pharma, Inc.
Mar 25, 2016	CAP-BIOTIN 100 MG, Rx Only, Compounded by RELIABLE COMPOUNDING PHARMACY, 801 ...	Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine	Class I	Reliable Rexall-A Compounding Pharmacy
Mar 25, 2016	Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle...	Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release ta...	Class III	Bryant Ranch Prepack Inc.
Mar 24, 2016	Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for:...	Labeling: Incorrect or Missing Lot and/or Expiration Date	Class III	Lupin Limited
Mar 17, 2016	Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distribu...	Labeling: Incorrect or Missing Lot and/or Exp. Date	Class III	Impax Laboratories, Inc.
Mar 17, 2016	Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distribu...	Labeling: Incorrect or Missing Lot and/or Exp. Date	Class III	Impax Laboratories, Inc.
Mar 15, 2016	Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL ...	Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiratio...	Class III	Hospira Inc.
Mar 14, 2016	Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/m...	Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the...	Class II	Meditech Laboratories, Inc
Mar 14, 2016	Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 m...	Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the...	Class II	Meditech Laboratories, Inc
Mar 14, 2016	Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL...	Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the...	Class II	Meditech Laboratories, Inc
Mar 11, 2016	SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by J...	Labeling: Label Error on Declared Strength	Class III	Jubilant Draximage Inc
Feb 12, 2016	Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Do...	Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with a...	Class III	Apace KY LLC
Feb 10, 2016	Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle (2...	Labeling: Label Mix-Up	Class III	Pfizer Inc
Feb 2, 2016	Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection ...	Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect exp...	Class III	Hospira Inc.
Feb 2, 2016	Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial...	Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrec...	Class III	Isomeric Pharmacy Solution, LLC
Jan 18, 2016	Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL...	Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with re...	Class III	Bausch & Lomb, Inc.
Jan 18, 2016	Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only...	Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with re...	Class III	Bausch & Lomb, Inc.
Jan 18, 2016	Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister car...	Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.	Class II	Amerisource Health Services
Jan 18, 2016	Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrig...	Labeling: label error on declared strength.	Class II	Perrigo Company PLC
Jan 18, 2016	Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24...	Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with re...	Class III	Bausch & Lomb, Inc.
Jan 18, 2016	Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perri...	Labeling: label error on declared strength.	Class II	Perrigo Company PLC
Jan 5, 2016	Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g T...	Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which ...	Class I	Hospira Inc.
Dec 22, 2015	Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray...	Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo...	Class II	Grato Holdings, Inc.
Dec 22, 2015	Energique, Homeopathic Remedy, Muscle/Tendon Pain & Stress Relief, Topical Sp...	Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo...	Class II	Grato Holdings, Inc.
Dec 22, 2015	Energique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical Spr...	Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo...	Class II	Grato Holdings, Inc.
Dec 22, 2015	Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical...	Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo...	Class II	Grato Holdings, Inc.
Dec 22, 2015	Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml...	Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo...	Class II	Grato Holdings, Inc.
Dec 22, 2015	Energique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray, ...	Microbial Contamination of Non Sterile Products; testing revealed out of specification results fo...	Class II	Grato Holdings, Inc.
Dec 18, 2015	Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softge...	Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.	Class III	National Vitamin Co Inc
Dec 8, 2015	Lumizyme (alglucosidase alpha), 50 mg/vial, For Intravenous Infusion Only, Rx...	Labeling: Incorrect or Missing Lot and/or Exp Date	Class III	Genzyme Corporation
Dec 3, 2015	Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 2...	Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the la...	Class II	GlaxoSmithKline, 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.