Browse Drug Recalls

2,085 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,085 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 2,085 FDA drug recalls in 2013.

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DateProductReasonClassFirm
Oct 19, 2013 TRANEXAMIC ACID* 2 g/75 mL SOLUTION, Rx only, Specialty Medicine Compounding... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 Calcium Chloride* PF 500 mg/mL pref syringe, Rx only, Specialty Medicine Comp... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 Combo Eye Gel, HF COMBO EYE GEL* (cyclopentolate 2%, tropicamide 1%, diclofen... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 19, 2013 0.9% Sodium chloride a) DT-0.9% Sodium chloride* 100 mL Drug Study - IV 100 m... Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products ar... Class II Specialty Medicine Compounding Pharmacy
Oct 18, 2013 Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-pre... Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in th... Class I Hospira Inc.
Oct 18, 2013 Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compo... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Compounding Centre At Blue Ridge
Oct 18, 2013 Triple Mix Injectable (aka Dr Ungers Triple Rx; Dr Tortora's Triple Rx; Dr B... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Compounding Centre At Blue Ridge
Oct 18, 2013 Super Triple Mix Injectable, (aka Dr Lentz Triple Rx Injectable; Dr Kane's Su... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Compounding Centre At Blue Ridge
Oct 18, 2013 PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compou... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Compounding Centre At Blue Ridge
Oct 18, 2013 Quad Mix Injectable, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 260... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Compounding Centre At Blue Ridge
Oct 16, 2013 Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharm... Subpotent. drug Class III Taro Pharmaceuticals U.S.A., Inc.
Oct 15, 2013 Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administ... Defective Container: A lidding deformity allowed for the product to have out of specification res... Class II VistaPharm, Inc.
Oct 15, 2013 Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Deliver... Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot... Class I B. Braun Medical Inc
Oct 11, 2013 Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patie... Presence of Particulate Matter: Visible particles embedded in the glass identified during a retai... Class II Hospira Inc.
Oct 11, 2013 Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 10... Subpotent; Hydrochlorothiazide at the 9 month time point. Class II Sandoz Inc
Oct 11, 2013 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fli... Lack of assurance of sterility; equipment failure led to potential breach in asceptic process. Class II Hospira Inc.
Oct 11, 2013 Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose ... Presence of Precipitate; precipitation of drug product Class II Teva Pharmaceuticals USA
Oct 10, 2013 Bella Vi INSANE AMP'D Dietary Supplement capsules, 60 count bottles, www.Bell... Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phen... Class I Pure Edge Nutrition
Oct 10, 2013 Bella Vi INSANE Bee Pollen Dietary Supplement Capsules, 60 count bottles, www... Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phen... Class I Pure Edge Nutrition
Oct 10, 2013 Bella Vi BTrim MAX Dietary Supplement capsules, 60 count bottles, www.BellaVi... Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phen... Class I Pure Edge Nutrition
Oct 10, 2013 Bella Vi BTrim ULTIMATE BOOST Dietary Supplement capsules, 30 count bottles, ... Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phen... Class I Pure Edge Nutrition
Oct 10, 2013 Oxygen, Compressed USP, in an aluminum cylinder, Rx only, Airgas USA, LLC, Ra... Short Fill: Due to an error in the manufacturing process, cylinders in this lot may be empty and ... Class II Airgas Medical Services
Oct 10, 2013 Bella Vi AMP'D UP Advanced Weight Loss Dietary Supplement capsules, 60 count ... Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phen... Class I Pure Edge Nutrition
Oct 10, 2013 Bella Vi eXtreme ACCELERATOR Dietary Supplement Capsules, 30 count bottles, w... Marketed without an Approved NDA/ANDA; product was found to contain undeclared sibutramine & phen... Class I Pure Edge Nutrition
Oct 9, 2013 Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufac... Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended ... Class II Sandoz, Inc
Oct 9, 2013 Alprazolam Orally Disintegrating Tablets, USP 2 mg, 100 count bottles, Rx Onl... Failed Tablet/Capsule Specifications; partial tablet erosion resulting in tablet weights below sp... Class II Actavis Elizabeth LLC
Oct 7, 2013 Lidiy capsules Dietary Supplement. Each bottle contains 30 capsules. Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine Class I B @ B Trade Inc.
Oct 7, 2013 Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturi... CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current g... Class II Betachem, Inc.
Oct 7, 2013 Slim Expert softgel capsules Dietary Supplement. One month supply/ 30 softgel... Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine Class I B @ B Trade Inc.
Oct 7, 2013 Dexedrine¿ (Dextroamphetamine Sulfate) Spansules¿ Sustained Release Capsules ... Failed Dissolution Specifications: Out of Specification (OOS) test results for Hour-4 at the 32 m... Class II Amedra Pharmaceuticals LLC
Oct 7, 2013 Slim Fortune capsules Dietary Supplement. Each bottle contains 30 capsules. Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine Class I B @ B Trade Inc.
Oct 2, 2013 Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blist... Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mE... Class III Cardinal Health
Oct 2, 2013 Albuterol Sulfate Inhalation Solution, 0.083% 2.5 mg/3 mL for Oral Inhalatio... Lack of Assurance of Sterility: Nephron Pharmaceuticals Corporation conducted a routine periodic ... Class II Nephron Pharmaceuticals Corp.
Sep 30, 2013 G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b... Failed Content Uniformity Specifications; at the 18 month time point. Class III G & W Laboratories Inc
Sep 27, 2013 Virilis Pro, 450mg/capsule, Packaged in a 1 and 2 capsule blister packs and 1... Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredie... Class I Haute Health, LLC
Sep 27, 2013 PHUK Sexual Enhancement Ultimate Pleasure, 400mg/capsule, packaged in 1 and ... Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredie... Class I Haute Health, LLC
Sep 27, 2013 Prolifta Dietary Supplement Prolifta, 400mg/capsule, Packaged in 1 and 2 caps... Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingred... Class I Haute Health, LLC
Sep 26, 2013 LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 bl... CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Sep 26, 2013 CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card.... CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Sep 25, 2013 Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bot... Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate T... Class III Sandoz Incorporated
Sep 24, 2013 Badger Baby Broad Spectrum SPF 30 Zinc Oxide Sunscreen Lotion Chamomile & Cal... Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen ... Class II W.S. Badger Company Inc.
Sep 24, 2013 Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial, Rx Only,... Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) w... Class II Hospira Inc.
Sep 24, 2013 Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx On... Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) we... Class II Hospira Inc.
Sep 24, 2013 Badger Kids Broad Spectrum SPF30 Zinc Oxide Sunscreen Lotion Tangerine & Vani... Microbial Contamination of Non-Sterile Products; Selected lots of Badger Baby and Kids Sunscreen ... Class II W.S. Badger Company Inc.
Sep 23, 2013 Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Do... Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to d... Class II West-Ward Pharmaceutical Corp.
Sep 23, 2013 Next Choice" One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg... Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage. Class II Watson Laboratories Inc
Sep 23, 2013 Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single D... Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to d... Class II West-Ward Pharmaceutical Corp.
Sep 23, 2013 Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for S... Subpotent Class III Tolmar, Inc.
Sep 20, 2013 Acanya (Clindamycin Phosphate and Benzoyl Peroxide) Gel 1.2% and 2.5%, Net Wt... Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being carried out due to an in... Class III Valeant Pharmaceuticals North Am
Sep 19, 2013 ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Man... Discoloration; due to prolonged heat exposure. Class III Ferring Pharmaceuticals 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.