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Browse Drug Recalls

6,306 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,306 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 6,306 FDA drug recalls.

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DateProductReasonClassFirm
Feb 18, 2013 0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., La... Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrec... Class II Hospira Inc.
Feb 15, 2013 METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira,... Lack of Assurance of Sterility: There is the potential for the solution to leak from the administ... Class II Hospira Inc.
Feb 12, 2013 0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Onl... Lack of Assurance of Sterility: There is a potential for the solution to leak from the administra... Class II Hospira Inc.
Jan 25, 2013 Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible container,... Non-Sterility: Confirmed customer complaint of product contaminated with mold. Class I Hospira Inc.
Jan 10, 2013 Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hosp... Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial Class II Hospira, Inc.
Jan 8, 2013 0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 6... Lack of Assurance of Sterility: There is the potential for solution to leak from the administrati... Class II Hospira Inc.
Jan 3, 2013 Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use (NDC 49... Non-Sterility: one or more components of the kit have been found to be contaminated with yeast. Class I Mobius Therapeutics LLC
Dec 4, 2012 Cyanocobalamin 1000 mcg/ml, injection 30 mL, MDV, For Office Use Only, Green ... Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on t... Class I Green Valley Drugs
Dec 4, 2012 Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension, 1 mL Via... Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on t... Class I Green Valley Drugs
Nov 26, 2012 TORISEL Kit (temsirolimus) injection, 25 mg/mL, CONCENTRATED, Rx Only, Packa... Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the di... Class III Pfizer Inc.
Nov 21, 2012 Nalbuphine HCl Injection, 20 mg/mL, 10 mL Multiple-dose Fliptop Vial, Rx only... Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a mis... Class II Hospira, Inc.
Nov 6, 2012 VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vi... Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity... Class II Alkermes, Inc.
Oct 31, 2012 All Sterile Products manufactured by Ameridose LLC, Westborough, MA. A compl... Lack of assurance of sterility Class II Ameridose LLC
Oct 22, 2012 HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MA... Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of ... Class II Hospira Inc.
Oct 6, 2012 All Sterile Products manufactured by NECC (New England Compounding Center), F... Lack of Assurance of Sterility Class II New England Compounding Center
Oct 5, 2012 Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers... Non-Sterility: One confirmed customer report that product contained spore-like particulates, cons... Class I Hospira Inc.
Sep 27, 2012 CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2... Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. Class II Fresenius Kabi USA, LLC
Sep 27, 2012 MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vi... Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. Class II Fresenius Kabi USA, LLC
Sep 27, 2012 ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single D... Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles. Class II Fresenius Kabi USA, LLC
Sep 26, 2012 Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL an... Non-Sterility Class I New England Compounding Center
Sep 26, 2012 Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Comp... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL a... Non-Sterility Class I New England Compounding Center
Sep 26, 2012 Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Comp... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufact... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compo... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 m... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manu... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 ... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Pho... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufact... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL an... Non-Sterility Class I New England Compounding Center
Sep 26, 2012 Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Comp... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL a... Non-Sterility Class I New England Compounding Center
Sep 26, 2012 Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/m... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 26, 2012 Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New E... Lack of Assurance of Sterility Class II New England Compounding Center
Sep 5, 2012 Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (rec... Lack of Assurance of Sterility; container closure issues with the bulk batch. Class II F. Hoffmann-LaRoche Ltd.
Aug 28, 2012 I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, O... Lack of Assurance of Sterility: The product is being recalled because the product label does not ... Class II James G. Cole, Inc.
Aug 28, 2012 Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, ... Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Class II Hospira Inc.
Aug 28, 2012 Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 m... Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial Class II Hospira Inc.
Jul 23, 2012 CMS-2374-R4 Custom US Breast Core Biopsy Tray, Sterile, contains Sodium Chlor... Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride b... Class II Custom Medical Specialties, Inc.
Jul 23, 2012 CMS-8934 Custom Phlebectomy Tray, Sterile, contains Sodium chloride 0.9% 50 m... Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride b... Class II Custom Medical Specialties, Inc.
Jul 23, 2012 Custom Access Tray, Sterile, contains Sodium Chloride 0.9% 50 mL, Re-order #:... Lack of Assurance of Sterility; the firm's medical trays contain Hospira's 0.9% Sodium Chloride b... Class II Custom Medical Specialties, Inc.
May 25, 2012 ALPROSTADIL 10MCG/ML INJECTABLE 10 ML, 20 ML, 3 ML, 30 ML, 5 ML, 6 ML; ALPRO... Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012 AFLIBERCEPT, SDPF - (0.05ML SYRINGE, 31G, 5/16") 40MG/ML INJECTABLE 0.35 ML, ... Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012 CYCLOPENT/PHENYLEPH/TROPICAMIDE/PROPARACAINE 2%/2.5%/1%/0.5% OPHTHALMIC 5 ML ... Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012 EPINEPHRINE **(25X1ML AMPULS) 1:1000 1MG/ML INJECTABLE 25 ML; EPINEPHRINE HC... Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012 ENGERIX-B, SDV** 20MCG/ML INJECTABLE 1 ML (1 PRODUCT) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012 ATROPINE SULFATE 0.4MG/ML INJECTABLE 12 ML, 2 ML, 20 ML, 24 ML, 25 ML, 3 ML;... Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab
May 25, 2012 FORSKOLIN/PHENTOLAMINE 200MCG / 2MG INJECTABLE 5 ML (1 PRODUCT) Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs d... Class II Franck's Lab Inc., d.b.a. Franck's Compounding Lab

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.