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Browse Drug Recalls

54 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 54 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 54 FDA drug recalls.

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DateProductReasonClassFirm
Feb 7, 2024 Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MF... cGMP Deviations: Products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Sterile Water for Injection USP, 2000 mL, Rx only, Baxter Healthcare Corp., N... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
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.
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.
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 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.
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.
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.
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 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 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.
May 21, 2013 Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 20... Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p... Class II Baxter Healthcare Corp.
May 21, 2013 0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (ND... Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p... Class II Baxter Healthcare Corp.
May 21, 2013 Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Bax... Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p... Class II Baxter Healthcare Corp.
May 21, 2013 5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only,... Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p... Class II Baxter Healthcare Corp.
May 21, 2013 Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plast... Lack of Assurance of Sterilty: Specific lot numbers of these products have been identified for po... Class II Baxter Healthcare Corp.
May 21, 2013 Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Cont... Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p... 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.

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.