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Browse Drug Recalls

85 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 85 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 85 FDA drug recalls.

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DateProductReasonClassFirm
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.
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.
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.
Nov 21, 2013 5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx... Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to... Class I Baxter Healthcare Corp.
Nov 18, 2013 Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1... Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. Class I Baxter Healthcare Corp.
Nov 18, 2013 Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% De... Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. Class I Baxter Healthcare Corp.
Nov 18, 2013 Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL... Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. Class I Baxter Healthcare Corp.
Nov 12, 2013 10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for ... Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be... Class II Baxter Healthcare Corp.
Jul 24, 2013 DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextro... Defective Container: There is a potential for frangible components to be broken, resulting in a l... Class II Baxter Healthcare Corp.
Feb 27, 2013 0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, ... Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injec... Class II Baxter Healthcare Corp.
Sep 21, 2012 0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, pr... Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... Class II Baxter Healthcare Corp.
Sep 21, 2012 5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVI... Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... Class II Baxter Healthcare Corp.
Sep 21, 2012 5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product cod... Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... Class II Baxter Healthcare Corp.
Sep 21, 2012 Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, produ... Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... Class II Baxter Healthcare Corp.
Sep 21, 2012 10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Ba... Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trac... Class II 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.