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Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Drug Recalls

119 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 119 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 119 FDA drug recalls.

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DateProductReasonClassFirm
Aug 1, 2018 Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% D... Superpotent Drug: High out of specification results for levofloxacin resulting in increased conce... Class III Baxter Healthcare Corporation
Nov 10, 2017 Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx O... Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of... Class I Baxter Healthcare Corporation
Sep 15, 2017 Intralipid 20%, A 20% I.V. Fat Emulsion, 100 ml bag, Rx only, Manufactured by... Temperature Abuse: A portion of this product lot was exposed to subfreezing temperatures, which i... Class I Baxter Healthcare Corporation
Jul 6, 2017 0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxt... Lack of Assurance of Sterility: Bags have the potential to leak. Class II Baxter Healthcare Corporation
Jul 6, 2017 5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxte... Lack of Assurance of Sterility: Bags have the potential to leak. Class II Baxter Healthcare Corporation
Jul 6, 2017 0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Ba... Lack of Assurance of Sterility: Customer complaints for leaking bags. Class II Baxter Healthcare Corporation
May 15, 2017 Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intrav... Lack of assurance of sterility: customer complaints received for the presence of leaks. Class II Baxter Healthcare Corporation
May 15, 2017 Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose ... Lack of assurance of sterility: customer complaints received for the presence of leaks. Class II Baxter Healthcare Corporation
Dec 6, 2016 Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intrav... Lack of Assurance of Sterility: confirmed customer complaints of leaking bags. Class II Baxter Healthcare Corporation
Dec 6, 2016 10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx on... Discoloration: there were customer reports of yellow discolored solution. The yellow coloration i... Class II Baxter Healthcare Corporation
Apr 12, 2016 Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium... Discoloration: presence of atypical yellow discoloration of the solution . Class II Baxter Healthcare Corp.
Feb 5, 2016 0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthca... PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identifi... Class II Baxter Healthcare Corp.
Jan 21, 2016 CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose... Presence of Particulate Matter: identified as dried skin. Class I Baxter Healthcare Corp.
Jan 21, 2016 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX S... Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of ste... Class II Baxter Healthcare Corp.
Jan 21, 2016 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX S... Presence of Particulate Matter: identified as cardboard. Class I Baxter Healthcare Corp.
Jan 21, 2016 Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Singl... Presence of Particulate Matter: identified as a cloth fiber. Class I Baxter Healthcare Corp.
Dec 15, 2015 Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bu... Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in th... Class I Baxter Healthcare Corp.
Dec 15, 2015 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx... Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in th... Class I Baxter Healthcare Corp.
Sep 2, 2015 0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Singl... Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surf... Class II Baxter Healthcare Corporation
Jul 17, 2015 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Si... Presence of Particulate Matter: Customer complaint for an insect found free floating inside a sin... Class I Baxter Healthcare Corp.
Jul 17, 2015 0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags,... Presence of Particulate Matter: Customer complaint for an insect found free floating inside a sin... Class I Baxter Healthcare Corp.
Jul 2, 2015 0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxt... Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint ... Class II Baxter Healthcare Corp.
Jun 3, 2015 Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 50... Subpotent Drug; out of specification results for heparin raw material Class II Baxter Healthcare Corp
Mar 24, 2015 10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Bax... Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Class I Baxter Healthcare Corp.
Mar 24, 2015 Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by ... Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Class I Baxter Healthcare Corp.
Mar 24, 2015 5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxte... Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Class I Baxter Healthcare Corp.
Mar 24, 2015 0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactu... Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Class I Baxter Healthcare Corp.
Mar 23, 2015 Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose... Lack of Assurance of Sterility; increased complaints received for leaks Class II Baxter Healthcare Corp
Mar 23, 2015 0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi P... Lack of Assurance of Sterility; increased complaints received for leaks Class II Baxter Healthcare Corp
Mar 18, 2015 0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx ... Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which ma... Class II Baxter Healthcare Corp.
Mar 18, 2015 5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Man... Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which ma... Class II Baxter Healthcare Corp.
Dec 23, 2014 Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRA... Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam. Class II Baxter Healthcare Corp.
Dec 4, 2014 0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, ... Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue ... Class I Baxter Healthcare Corp
Nov 25, 2014 Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% De... Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal Class II Baxter Healthcare Corp.
Nov 10, 2014 Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose con... Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were inc... Class II Baxter Healthcare Corp.
Oct 30, 2014 Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500... Subpotent Drug: Heparin raw material was found to have low potency Class II Baxter Healthcare Corp.
Sep 29, 2014 DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, ... Lack of Assurance of Sterility: A small cut in the solution bag may have been introduced during t... Class II Baxter Healthcare Corp.
Sep 8, 2014 Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq... Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride inject... Class II Baxter Healthcare Corp
Aug 7, 2014 Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextro... Presence of Particulate Matter: particulate matter was found during the manufacturing process. Class I Baxter Healthcare Corp.
Aug 4, 2014 ProSol - sulfite-free (Amino Acid) Injection, 20%, 2000 mL VIAFLEX container ... Presence of Particulate Matter: identification of particulates in a retention sample that have be... Class II Baxter Healthcare Corp
Jul 30, 2014 0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxte... Lack of Assurance of Sterility; complaints of mold in the overpouch Class II Baxter Healthcare Corp.
Jul 11, 2014 0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container ba... Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. Class I Baxter Healthcare Corp.
Jul 11, 2014 Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Con... Presence of Particulate Matter: particulate matter identified as fibers and/or plastics Class I Baxter Healthcare Corp.
Jul 11, 2014 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Si... Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. Class I Baxter Healthcare Corp.
Jun 16, 2014 Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500... Presence of Particulate Matter: Complaints received of discolored solution identified as subvisib... Class II Baxter Healthcare Corp.
May 12, 2014 0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, B... Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes Class I Baxter Healthcare Corp.
Apr 24, 2014 Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G342... Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting ... Class II Baxter Healthcare Corp.
Apr 21, 2014 0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufacture... Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irriga... Class II Baxter Healthcare Corp.
Feb 11, 2014 Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Fl... Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag ... Class I Baxter Healthcare Corp.
Nov 21, 2013 0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX... Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due t... Class I Baxter Healthcare Corp.

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.