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Browse Drug Recalls

22 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 22 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 22 FDA drug recalls.

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DateProductReasonClassFirm
Mar 31, 2025 PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL ... Lack of Assurance of Sterility: Leaking/damaged syringes. Class II Denver Solutions, LLC DBA Leiters Health
Mar 31, 2025 Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, ... Lack of Assurance of Sterility: Leaking/damaged syringes. Class II Denver Solutions, LLC DBA Leiters Health
Mar 31, 2025 Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, ... Lack of Assurance of Sterility: Leaking/damaged syringes. Class II Denver Solutions, LLC DBA Leiters Health
Mar 31, 2025 dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mc... Lack of Assurance of Sterility: Leaking/damaged syringes. Class II Denver Solutions, LLC DBA Leiters Health
Mar 31, 2025 Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx ... Lack of Assurance of Sterility: Leaking/damaged syringes. Class II Denver Solutions, LLC DBA Leiters Health
Feb 20, 2024 Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile inje... Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delaminat... Class II Denver Solutions, LLC DBA Leiters Health
Feb 20, 2024 Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Sing... Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delaminat... Class II Denver Solutions, LLC DBA Leiters Health
Feb 20, 2024 Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Comp... Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delaminat... Class II Denver Solutions, LLC DBA Leiters Health
Dec 28, 2023 PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Ite... Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... Class I Denver Solutions, LLC DBA Leiters Health
Dec 28, 2023 PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item... Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... Class I Denver Solutions, LLC DBA Leiters Health
Dec 28, 2023 FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL)... Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... Class I Denver Solutions, LLC DBA Leiters Health
Dec 28, 2023 VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F320... Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... Class I Denver Solutions, LLC DBA Leiters Health
Dec 28, 2023 FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL)... Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... Class I Denver Solutions, LLC DBA Leiters Health
Dec 28, 2023 VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F32... Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... Class I Denver Solutions, LLC DBA Leiters Health
Oct 4, 2023 Oxytocin synthetic, 30 Units added to 0.9% Sodium Chloride 500mL IV Bag (0.06... Labeling: Not Elsewhere Classified Class III Denver Solutions, LLC DBA Leiters Health
Oct 4, 2023 VANCOmycin HCI PF, 1.5 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only... Labeling: Not Elsewhere Classified Class III Denver Solutions, LLC DBA Leiters Health
Oct 4, 2023 VANCOmycin HCI PF, 1.25 g added to 0.9% Sodium Chloride 250 mL IV Bag, Rx onl... Labeling: Not Elsewhere Classified Class III Denver Solutions, LLC DBA Leiters Health
Feb 21, 2023 Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV B... CGMP DEVIATIONS Class II Denver Solutions, LLC DBA Leiters Health
Feb 21, 2023 Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters... CGMP DEVIATIONS Class II Denver Solutions, LLC DBA Leiters Health
Feb 21, 2023 Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiter... CGMP DEVIATIONS Class II Denver Solutions, LLC DBA Leiters Health
Feb 21, 2023 Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV ... CGMP DEVIATIONS Class II Denver Solutions, LLC DBA Leiters Health
Nov 29, 2021 Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, ... Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5... Class II Denver Solutions, LLC DBA Leiters Health

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.