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Browse Drug Recalls

48 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 48 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 48 FDA drug recalls.

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DateProductReasonClassFirm
Nov 6, 2025 Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only... Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. Class I Fresenius Kabi USA, LLC
Nov 22, 2022 Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine... Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. Class II Fresenius Kabi USA, LLC
Nov 22, 2022 Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epineph... Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. Class II Fresenius Kabi USA, LLC
Nov 22, 2022 Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine... Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. Class II Fresenius Kabi USA, LLC
Mar 4, 2022 Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 t... Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts o... Class I Fresenius Kabi USA, LLC
Jun 25, 2021 Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Inje... Low out of specification results for epinephrine assay. Class II Fresenius Kabi USA LLC
Dec 23, 2020 Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single ... Presence of Particulate Matter - found in reserve sample vials at the firm. Class I Fresenius Kabi USA, LLC
Dec 17, 2020 Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), package... Presence of Particulate Matter - found in reserve sample vials at the firm. Class II Fresenius Kabi USA, LLC
Dec 10, 2020 Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 m... Subpotent Drug: Low out-of-specification assay results for the epinephrine component. Class II Fresenius Kabi USA, LLC
Nov 17, 2020 Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg... Cross Contamination with other products: trace amounts of lidocaine Class I Fresenius Kabi USA, LLC
Nov 17, 2020 DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill... Cross Contamination with Other Products: trace amounts of octreotide found during testing Class III Fresenius Kabi USA, LLC
Jul 22, 2020 Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 m... Cross Contamination with other products: trace amounts of lidocaine Class I Fresenius Kabi USA, LLC
Jul 13, 2020 Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx on... Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly sta... Class III Fresenius Kabi USA, LLC
Apr 20, 2020 Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), package... Presence of Particulate Matter - found in reserve sample vials at the firm. Class II Fresenius Kabi USA, LLC
Apr 20, 2020 Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single ... Presence of Particulate Matter - found in reserve sample vials at the firm. Class I Fresenius Kabi USA, LLC
Jun 28, 2019 Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 ... Presence of Particulate Matter; glass particulates Class I Fresenius Kabi USA, LLC
May 22, 2019 Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kab... Failed Impurities/Degradation Specifications. Class III Fresenius Kabi USA, LLC
Nov 15, 2018 SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 2... Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect state... Class I Fresenius Kabi USA, LLC
Nov 15, 2018 SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 2... Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect state... Class I Fresenius Kabi USA, LLC
Jan 16, 2018 Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius K... Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related ... Class III Fresenius Kabi USA, LLC
Oct 27, 2017 Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2m... Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Cont... Class I Fresenius Kabi USA, LLC
Mar 16, 2017 Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Phar... Subpotent Drug Class III Fresenius Kabi USA, LLC
Mar 8, 2017 hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, pa... Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. wer... Class II Mckesson Medical Surgical
Dec 16, 2016 MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per c... Failed Impurities/Degradation Specifications Class II Fresenius Kabi USA, LLC
May 4, 2016 OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose... Failed Impuities/Degradation Specifications Class II Fresenius Kabi USA, LLC
May 4, 2016 OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose... Failed Impuities/Degradation Specifications Class II Fresenius Kabi USA, LLC
Apr 25, 2016 Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Do... Presence of Particulate Matter: Glass particulate found in sterile injectable product Class II Fresenius Kabi USA, LLC
Apr 7, 2016 Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi... Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of... Class III Fresenius Kabi USA, LLC
Apr 5, 2016 Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intraven... Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Pres... Class II Fresenius Kabi USA, LLC
Jul 28, 2015 Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; sin... Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) ... Class III Fresenius Kabi USA, LLC
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.