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Browse Drug Recalls

515 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 515 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 515 FDA drug recalls.

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DateProductReasonClassFirm
Nov 18, 2013 50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass conta... Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and ... Class I Baxter Healthcare Corp.
Nov 4, 2013 Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300... Presence of Particulate Matter: Failed the appearance test for the presence of visible particles. Class I Alexion Pharmaceuticals, Inc.
Oct 31, 2013 Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fres... Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial... Class II Fresenius Kabi USA, LLC
Oct 24, 2013 Copaxone (glatiramer acetate injection), 20 mg/1 mL, 1 mL pre-filled syringe,... Presence of Particulate Matter: A foreign particle found in a pre-filled syringe was reported thr... Class II Teva Pharmaceuticals USA
Oct 19, 2013 Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specia... Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold,... Class I Specialty Medicine Compounding Pharmacy, P.C.
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 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.
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 17, 2013 Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syring... Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefi... Class II Amgen, Inc.
Sep 16, 2013 1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., L... Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochlor... Class I Hospira, Inc.
Sep 6, 2013 Concentrated Motrin (ibuprofen) Infants' Drops Oral Suspension, Original Berr... Presence of Foreign Substance: process-related particulates which may be associated with the raw ... Class II Mcneil Consumer Healthcare, Div Of Mcneil-ppc, ...
Aug 30, 2013 Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx onl... Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as... Class I Hospira Inc.
Aug 29, 2013 Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-u... Presence of Particulate Matter; Glass particulates observed in vials Class I Cubist Pharmaceuticals, Inc.
Aug 29, 2013 5% Lidocaine HCl and 7.5% Dextrose Injection, USP, 2 mL Single Dose Ampuls, R... Presence of Particulate Matter; report of visible particulates in the glass ampule Class II Hospira Inc.
Aug 14, 2013 Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Unit... Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and c... Class II Hospira Inc.
Aug 1, 2013 Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Via... Presence of particulate matter: characterized as thin colorless flakes that are visually and chem... Class II Nexus Pharmaceuticals Inc
Jul 17, 2013 Acyclovir Tablets USP 800 mg ,(NDC 60505-5307-1), Rx only, Manufactured by A... Presence of Particulate Matter: Product from lot KF2199, may contain tablets with pieces of nitri... Class II Apotex Inc.
Jul 12, 2013 0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira ... Presence of particulate matter: visible free floating and partially embedded particulate matter i... Class I Hospira Inc.
Jul 12, 2013 0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira ... Presence of particulate matter: visible free floating and partially embedded particulate matter i... Class I Hospira Inc.
Jul 1, 2013 Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose ... Presence of particulate matter: characterized as thin colorless flakes that are visually and che... Class II Fresenius Kabi USA, LLC
Jun 27, 2013 Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial,... Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of a... Class II Hospira Inc.
Jun 4, 2013 Cleocin Phosphate (clindamycin Injection), USP, a) 600 mg/4mL (150 mg/mL) ADD... Presence of Particulate Matter: Firm is recalling a small number of vials with very small reflect... Class II Pharmacia & Upjohn LLC
May 30, 2013 Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injectio... Presence of Particulate Matter; particulate found in retain samples Class III Pharmalucence, Inc.
May 25, 2013 Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 ... Presence of Particulate Matter: Glass particulate matter was observed in a retention sample durin... Class I Fresenius Kabi USA, LLC
May 25, 2013 Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patie... Presence of Particulate Matter; single visible particulate was identified during a retain sample ... Class II Hospira Inc.
May 20, 2013 Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL S... Presence of Particulate Matter: Found during examination of retention samples. Class I Sandoz Incorporated
May 20, 2013 Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, ... Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles f... Class II Hospira, Inc.
May 2, 2013 Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Sin... Presence of Particulate Matter: visible particles were identified floating in the primary container. Class II Hospira Inc.
Apr 8, 2013 Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patie... Presence of Particulate Matter: A single visible particulate was identified during a retain sampl... Class II Hospira Inc.
Mar 29, 2013 0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hos... Presence of Particulate Matter: reports of small grey/brown particles found in the primary contai... Class I Hospira Inc.
Mar 11, 2013 LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP, 20 mg/25 mg, 100 (NDC 60429-... Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel parti... Class II Gsms
Feb 25, 2013 Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient inf... Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed ... Class II Hospira Inc.
Jan 31, 2013 Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx on... Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir ... Class I Gilead Sciences, Inc.
Dec 7, 2012 Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (N... Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant ... Class II West-ward Pharmaceutical Corp.
Nov 30, 2012 Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-c... Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel parti... Class II West-ward Pharmaceutical Corp.
Nov 21, 2012 Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector S... Presence of Particulate Matter; fibers identified as cellulose and polyvinyl Class I Bracco Diagnostic Inc
Nov 21, 2012 Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66... Presence of Particulate Matter; fibers identified as cellulose and polyvinyl Class I Bracco Diagnostic Inc
Nov 15, 2012 Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusio... Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observ... Class II Hospira Inc.
Nov 9, 2012 Atorvastatin Calcium Tablets, 40 mg, a) 90 tablets per bottle, b) 500 tablets... Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg ma... Class II Ranbaxy Inc.
Nov 9, 2012 Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle, Rx only, Manufact... Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg ma... Class II Ranbaxy Inc.
Nov 9, 2012 Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufact... Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg ma... Class II Ranbaxy Inc.
Nov 8, 2012 Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Steri... Crystallization: Product is being recalled due to visible particulates identified during a retain... Class I Hospira Inc.
Nov 8, 2012 Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Steri... Crystallization: Product is being recalled due to visible particulates identified during a retain... Class I Hospira Inc.
Oct 25, 2012 Epinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., ... Presence of Particulates; may contain glass particles Class II Hospira Inc.
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.
Oct 4, 2012 Lidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, ... Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded i... Class II Hospira, Inc.
Aug 31, 2012 0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hosp... Presence of Particulate Matter; product may contain fibrous material Class I Hospira Inc.
Aug 29, 2012 Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusio... Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample... Class II Hospira Inc.
Aug 14, 2012 Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials ... Presence of Particulate Matter; potential for charcoal particulates Class III Bracco Diagnostic 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.