FDA Drugs recall ·
medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL… recall
- Recall number
- D-0185-2025
- Date
- (initiated December 18, 2024)
- Company / brand
- Eugia US LLC
279 Princeton Hightstown Rd, East Windsor, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 19872 vials
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
medroxyPROGESTERone Acetate Injectable Suspension, USP, 150mg per mL, Rx only, 1 mL Single-Dose Vial, Mfd in India for: Eugia US LLC, NJ 08520 NDC 55150-329-01 Shipper label: medroxyPROGESTERone Acetate Injectable Suspension, USP, 150 mg per mL, Distributed by: Eugia US LLC, NJ, Manufactured by: Eugia Pharma Specialties Limited, India
Why was it recalled?
CGMP Deviations
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot No.: 1MP24069, Exp.: 08/2026
Distribution
Nationwide in the US
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0185-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.