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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
May 23, 2024 Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL ... Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phos... Class II Eugia US LLC
Feb 20, 2024 Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial,... Failed Impurities/Degradation Specifications: Out of specification for organic impurities Class II Eugia US LLC
Feb 20, 2024 Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Dis... Failed Impurities/Degradation Specifications: Out of specification for organic impurities Class II Eugia US LLC
Feb 7, 2024 Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vi... cGMP Deviations: Products were stored outside the drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Sep 28, 2023 Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL... Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial.... Class II Eugia US LLC
Dec 28, 2022 Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL V... Presence of Particulate Matter: Customer complaint of dark particles found inside the vial Class II Eugia US LLC
Sep 30, 2022 Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled... Subpotent Drug: Out of specification for assay Class II AuroMedics Pharma LLC
Sep 26, 2022 Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx ... Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate fl... Class II AuroMedics Pharma LLC
Sep 26, 2022 Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dos... Presence of Particulate Matter: Piece of metal found in a vial Class III AuroMedics Pharma LLC
Apr 13, 2022 Bupivacaine HCl Injection, Single Dose Vial, 0.75%, 10 mL/7.5 mg/mL, Rx only,... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Sumatriptan Injection, USP, 6mg/0.5 mL, packaged in a box of 5 x 0.5 mL singl... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Olanzapine single dose vial Lyophilized, 10 mg, Rx only, MFG: Auromedics Phar... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Bupivacaine HCl Injection, single dose vial, 0.5%, 30 mL/5 mg/mL, Rx only, Ma... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Bupivacaine HCl Injection, Multi dose vial, 0.25%, 50 mL/2.5 mg/mL, Rx only, ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Azithromycin for Injection USP Vial, 500 mg per vial, Rx only, Manufacturer: ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Bupivacaine HCl Injection, Multi dose vial, 0.50%, 50 mL/5 mg/mL, Rx only, Ma... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Dexmedetomidine HCL Single Dose Vial 200 mcg per 2 mL (100mcg/mL), Rx only, M... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 5, 2022 Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL ... Subpotent Drug: Out of Specification results for Assay Class III Aurobindo Pharma USA Inc.
Jan 26, 2022 Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged ... Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot Class I AuroMedics Pharma LLC
Dec 30, 2020 Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vi... Discoloration and failed pH specifications Class II AuroMedics Pharma LLC
Feb 7, 2020 Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose... Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found ... Class III AuroMedics Pharma LLC
Feb 7, 2020 Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count b... Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cabl... Class II AuroMedics Pharma LLC
Dec 2, 2019 Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For... Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution. Class III AuroMedics Pharma LLC
Nov 25, 2019 Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-co... Discoloration: Product complaints of discoloration after reconstitution of vials. Class II AuroMedics Pharma LLC
Nov 20, 2019 Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by... Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bo... Class I AuroMedics Pharma LLC
Nov 20, 2019 Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by:... Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bo... Class I AuroMedics Pharma LLC
Nov 19, 2019 Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma US... Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 coun... Class II AuroMedics Pharma LLC
Nov 12, 2019 Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx... Discoloration; Hazy solution found in one vial instead of a clear solution. Class II AuroMedics Pharma LLC
Nov 11, 2019 Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL... Crystallization: Presence of visible particulate matter. Class III AuroMedics Pharma LLC
Nov 11, 2019 Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, p... Presence of Foreign Substance: Foreign material found inside the vial. Class II AuroMedics Pharma LLC
Nov 11, 2019 Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL S... Crystallization: Presence of visible particulate matter. Class III AuroMedics Pharma LLC
Nov 11, 2019 Amiodarone Hydrochloride Injection, USP, 150 mg per 3 mL (50 mg / mL), 3 mL S... Crystallization: Presence of visible particulate matter. Class III AuroMedics Pharma LLC
Nov 6, 2019 DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed... CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules ... Class II AuroMedics Pharma LLC
Nov 6, 2019 Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed b... CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules ... Class II AuroMedics Pharma LLC
Nov 6, 2019 Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by... CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules ... Class II AuroMedics Pharma LLC
Nov 6, 2019 Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by... CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules ... Class II AuroMedics Pharma LLC
Nov 6, 2019 Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL... CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules ... Class II AuroMedics Pharma LLC
Sep 23, 2019 Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp,... CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles... Class III AuroMedics Pharma LLC
Jul 2, 2018 Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Do... Presence of Particulate Matter: identified as glass and silicone material Class I AuroMedics Pharma LLC
May 1, 2018 Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intr... Presence of Particulate Matter: confirmed customer report for presence of visible particulate mat... Class I AuroMedics Pharma LLC
May 1, 2018 Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular... Presence of Particulate Matter: confirmed customer report of the presence of visible particulate ... Class I AuroMedics Pharma LLC
Mar 27, 2018 Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/m... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administratio... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 m... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL)... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Mar 27, 2018 Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 m... Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found betwee... Class II AuroMedics Pharma LLC
Jan 12, 2018 Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-U... Presence of Particulate Matter; contains visible particulate matter identified as mold. Class I AuroMedics Pharma 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.