FDA Recall D-0185-2025

Eugia US LLC · East Windsor, NJ

Class II Ongoing 512 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot No.: 1MP24069, Exp.: 08/2026

Quantity: 19872 vials

Reason for recall

CGMP Deviations

Recall record

Recall number: D-0185-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the US
Recall initiated: 2024-12-18
Classified by FDA Center: 2025-01-06
FDA published: 2025-01-15
Recalling firm: Eugia US LLC
Firm location: East Windsor, NJ

Drug identification

Brand name(s): MEDROXYPROGESTERONE ACETATE
Generic name(s): MEDROXYPROGESTERONE ACETATE
Manufacturer(s): Eugia US LLC
NDC(s): 55150-329, 55150-330
Route(s): INTRAMUSCULAR

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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