Progesterone Injection USP recall
FDA recall D-0186-2025 · initiated Dec 27, 2024
Eugia US LLC recalled Progesterone Injection USP in Dec 2024 — an FDA Class II recall (D-0186-2025) because Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
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: 17,300 10-mL vials
Details
- Product
- Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ 08520 NDC # 55150-306-10
- Recalling company
- Eugia Pharma
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Distributed Nationwide in the USA.
- Initiated
- Dec 27, 2024
- FDA report date
- Jan 15, 2025
Frequently asked
- Was Progesterone Injection USP recalled?
- Eugia US LLC recalled Progesterone Injection USP in Dec 2024 — an FDA Class II recall (D-0186-2025) because Presence of Particulate Matter: A market complaint was received of a glass piece in the vial. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Progesterone Injection USP recalled?
- Per the FDA enforcement record, the reason for recall D-0186-2025 was: Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
- Is a recalled Progesterone Injection USP 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 Progesterone Injection USP are affected?
- Distributed: Distributed Nationwide in the USA.. The recall covers these lots — Batch # 1PR24010, Expiry: 02/28/2027. 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-0186-2025.