Testosterone Cypionate Injection 200 mg/mL Recalled for Sterility Assurance
Empower Pharmacy is recalling Testosterone Cypionate Injection 200 mg/mL (Lot 202364, 8,230 vials) distributed nationwide because the manufacturer cannot assure the product's sterility. Consumers should stop using the product and consult their healthcare provider.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of a sterile injectable product where sterility assurance cannot be verified. Class II recalls with potential for serious health consequences (infection risk from non-sterile injectables) meet the Severe threshold, even without reported illnesses.
Plain-English summary
Empower Clinic Services, LLC, doing business as Empower Pharmacy, is recalling Testosterone Cypionate Injection, 200 mg/mL, a prescription-only, controlled substance compounded drug supplied in 5 mL sterile multiple-dose vials. The recall involves Lot 202364, compounded on August 20, 2024, with a beyond-use date of May 28, 2025. Approximately 8,230 vials have been distributed nationwide.
The recall is being conducted because the manufacturer lacks assurance of sterility for this product. Sterility is critical for injectable medications to prevent serious infections.
Patients who have received or are currently using this product should stop use immediately and contact their healthcare provider to discuss their medication needs. Healthcare providers with questions may call Empower Pharmacy at (877) 562-8577. The product was compounded and distributed by Empower Pharmacy, located at 7601 N Sam Houston Parkway West, Suite 100, Houston, TX 77064.
The recalled product
- 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.
- Category
- Drug — Injectable / Compounded
- Affected units
- 8,230
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 202364
- Exp 5/28/2025
Distribution
Distributed nationwide across the United States.
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