Browse Drug Recalls

17 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17 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 17 FDA drug recalls.

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DateProductReasonClassFirm
May 29, 2025 Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL ... Failed Stability Specifications: Out of specification results for the Color Absorbance test duri... Class II Eugia US LLC
Apr 25, 2025 Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Sin... Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 21, 2025 Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose... Out-of-Specification test results were obtained in at long term conditions during 3 month's stabi... Class II Eugia US LLC
Apr 21, 2025 Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-d... Out-of-Specification test results were obtained in at long term conditions during 3 month's stabi... Class II Eugia US LLC
Apr 10, 2025 Testosterone Cypionate Injection, USP, CIII, 200mg per mL, Rx only, 1mL Singl... cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. Class II Eugia US LLC
Dec 27, 2024 Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vi... Presence of Particulate Matter: A market complaint was received of a glass piece in the vial. Class II Eugia US LLC
Dec 18, 2024 medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only... CGMP Deviations Class II Eugia US LLC
Jul 26, 2024 Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose ... Presence of Particulate Matter: Complaint received of a glass particle in the vial. Class II Eugia US LLC
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
May 22, 2024 Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mf... Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide... Class III Eugia US LLC
Feb 22, 2024 Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, ... Failed Stability Specification: Water determination was found not complying with specification. Class II Eugia US LLC
Feb 20, 2024 Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL... Failed Dissolution Specifications 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 15, 2024 Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial ... Presence of Particulate Matter Class I Eugia US LLC
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

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.