BRANMOOR

THURSDAY · 14 MAY 2026

FDA Recall D-0258-2026

Advanced Pharmaceutical Technology, Inc. · Elmsford, NY

Class II Ongoing 223 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-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01

Lot / code: Lot #: P-22-3, Exp 06-2027

Quantity: 22,843 pellets

Reason for recall

Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.

Recall record

Recall number: D-0258-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: GA, NY, TX, Puerto Rico, United Kingdom, Malta, Greece
Recall initiated: 2025-10-03
Classified by FDA Center: 2026-01-14
FDA published: 2026-01-21
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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