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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.