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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.