Browse Drug Recalls

68 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 68 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 68 FDA drug recalls.

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DateProductReasonClassFirm
Jun 4, 2015 Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured ... Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degra... Class II Fresenius Kabi USA, LLC
Apr 28, 2015 KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electro... Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids Class II Fresenius Kabi USA, LLC
Nov 12, 2014 GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Do... Defective Container: Vials may be missing stoppers. Class II Fresenius Kabi USA, LLC
Aug 13, 2014 PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx o... CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several cr... Class II Fresenius Kabi USA, LLC
May 2, 2014 Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= pheny... Presence of Particular Matter: Potential glass delamination and consistent with glass particulate... Class II Fresenius Kabi USA, LLC
May 2, 2014 Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenyto... Presence of Particular Matter: Potential glass delamination and consistent with glass particulate... Class II Fresenius Kabi USA, LLC
Apr 14, 2014 HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi... Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperid... Class III Fresenius Kabi USA LLC
Jan 22, 2014 Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per... Subpotent; 18 month time point Class II Fresenius Kabi USA, LLC
Dec 6, 2013 FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Do... Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point Class III Fresenius Kabi USA, LLC
Nov 8, 2013 PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple ... Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinica... Class III Fresenius Kabi USA, LLC
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
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 24, 2013 Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM ... Subpotent Drug; 15-month stability test station Class II Fresenius Kabi USA, LLC
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 21, 2013 Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dos... Failed Impurities/Degradation Specification Class III 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 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 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

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.