FDA Recall D-0400-2025

Mckesson Medical-Surgical Inc. Corporate Office · Richmond, VA

Class II Ongoing 384 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, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-0330-01

Lot / code: Lot #: 1MP24042, Exp 6/30/26

Quantity: 3

Reason for recall

Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.

Recall record

Recall number: D-0400-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: N/A
Distribution: Distributed to Medical Facilities in MS and FL.
Recall initiated: 2025-04-25
Classified by FDA Center: 2025-05-01
FDA published: 2025-05-07
Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office
Firm location: Richmond, VA

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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