Drug FDA Class II Ongoing Foreign material

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

Eugia US LLC Published Jan 15, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Eugia US LLC or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.

Hazards

Glass · primary

Affected products (1)

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

PROGESTERONE · 17,300 10-mL vials

NDC: 55150-306, 55150-306-10

Code info: Batch # 1PR24010, Expiry: 02/28/2027

Affected areas

Nationwide

Timeline

Initiated

Dec 27, 2024
Published

Jan 15, 2025

Recall number: D-0186-2025
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.