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Browse Drug Recalls

9 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 9 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 9 FDA drug recalls.

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DateProductReasonClassFirm
Apr 13, 2022 Xylocaine + Epinephrine, multi dose vial 2%, 20 mL, 25 count box, Rx only, MF... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Xylocaine + Epinephrine, multi dose vial 1%, packaged in a) 20 mL, 25-count b... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Sep 17, 2021 Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only,... Defective container: Cracked vials leading to lack of sterility assurance Class II 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
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 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
Feb 1, 2013 CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, R... Labeling: Missing label Class III Fresenius Kabi USA LLC (FK USA)
Jan 22, 2013 IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose V... Crystallization: Active pharmaceutical ingredient is precipitating in product solution. Class II Fresenius Kabi USA LLC (FK USA)

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.