medroxyPROGESTERone Acetate Injectable Suspension recall
FDA recall D-0185-2025 · initiated Dec 18, 2024
Eugia US LLC recalled medroxyPROGESTERone Acetate Injectable Suspension in Dec 2024 — an FDA Class II recall (D-0185-2025) because CGMP Deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 19872 vials
Details
- 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
- Recalling company
- Eugia Pharma
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US
- Initiated
- Dec 18, 2024
- FDA report date
- Jan 15, 2025
Frequently asked
- Was medroxyPROGESTERone Acetate Injectable Suspension recalled?
- Eugia US LLC recalled medroxyPROGESTERone Acetate Injectable Suspension in Dec 2024 — an FDA Class II recall (D-0185-2025) because CGMP Deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was medroxyPROGESTERone Acetate Injectable Suspension recalled?
- Per the FDA enforcement record, the reason for recall D-0185-2025 was: CGMP Deviations
- Is a recalled medroxyPROGESTERone Acetate Injectable Suspension dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of medroxyPROGESTERone Acetate Injectable Suspension are affected?
- Distributed: Nationwide in the US. The recall covers these lots — Lot No.: 1MP24069, Exp.: 08/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0185-2025.