Medroxyprogesterone Acetate Injectable Suspension Recalled for Manufacturing Deviations
Eugia US LLC is recalling medroxyprogesterone acetate injectable suspension (150mg/mL) due to manufacturing practice deviations. This voluntary recall affects 19,872 vials distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of an injectable prescription medication with manufacturing practice deviations; no illnesses or injuries reported. Classified as High severity under the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medroxyprogesterone acetate injectable suspension, 150mg per mL, is being recalled by Eugia US LLC due to Current Good Manufacturing Practice (CGMP) deviations identified in the manufacturing process. The affected product is supplied in 1mL single-dose vials with lot number 1MP24069 (expiration 08/2026) and was manufactured in India by Eugia Pharma Specialties Limited.
The voluntary recall, initiated by the firm on December 18, 2024, affects approximately 19,872 vials distributed nationwide. This is a prescription injectable medication administered intramuscularly, marketed under National Drug Code (NDC) 55150-329-01 and related package codes.
No illnesses or injuries have been reported associated with this product to date. Patients currently using this medication should contact their healthcare provider or pharmacy to confirm whether they have received the affected lot and to discuss appropriate next steps. Healthcare providers and pharmacies should verify their inventory and quarantine any vials matching the identified lot number.
The recalled product
- Product
- MEDROXYPROGESTERONE ACETATE (MEDROXYPROGESTERONE ACETATE)
- Brand
- MEDROXYPROGESTERONE ACETATE
- Manufacturer
- Eugia US LLC
- Category
- Drug — Contraceptive Injectable
- Hazard
- Affected units
- 19,872
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot No.: 1MP24069
- Exp.: 08/2026
UPCs (2)
- 0355150330010
- 0355150329014
Distribution
Distributed nationwide across the United States.
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