BRANMOOR

THURSDAY · 14 MAY 2026

FDA Recall D-0531-2025

Advanced Pharmaceutical Technology, Inc. · Elmsford, NY

Class II Ongoing 349 days on record

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

Product

TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsford, NY 10523. NDC 57377-200-01

Lot / code: Lot P-24-1; Exp. 02/28/2027

Quantity: 26 vials

Reason for recall

Marketed Without an Approved NDA/ANDA

Recall record

Recall number: D-0531-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: NY, NJ
Recall initiated: 2025-05-30
Classified by FDA Center: 2025-07-16
FDA published: 2025-07-02
Recalling firm: Advanced Pharmaceutical Technology, Inc.
Firm location: Elmsford, NY

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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