FDA Recall D-0420-2025

Empower Clinic Services, LLC dba Empower Pharmacy · Houston, TX

Class II Ongoing 377 days on record

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

Product

Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose Vial, Compounded by: Empower Pharmacy, 7601 N Sam Houston Pkwy W Ste 100, Houston, TX, 77064, Phone: (877) 562-8577, Compounding Date: 08/20/2024, Beyond Use by Date: 05/28/2025, Lot 202364.

Lot / code: Lot #: 202364, Exp 5/28/2025

Quantity: 8,230 vials

Reason for recall

Lack of Assurance of Sterility

Recall record

Recall number: D-0420-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: USA Nationwide
Recall initiated: 2025-05-02
Classified by FDA Center: 2025-05-09
FDA published: 2025-05-21
Recalling firm: Empower Clinic Services, LLC dba Empower Pharmacy
Firm location: Houston, TX

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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