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Class II: temporary or reversible health riskOngoing

Empower Clinic Services, LLC dba Empower Pharmacy Testosterone Cypionate Injection Recall

Testosterone Cypionate Injection, 200 mg/mL, CIII, Rx Only, 5 mL Sterile Multiple-Dose…

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

Risk level
Class II
Reported by FDA
May 21, 2025
Recall ID
D-0420-2025
Check your lot numberHow we source this data

Summary

Empower Clinic Services, LLC dba Empower Pharmacy recalled Testosterone Cypionate Injection starting May 2, 2025. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0420-2025 on May 21, 2025. Reason: Lack of Assurance of Sterility. Status: Ongoing.

Why it was recalled

Lack of Assurance of Sterility

Product description

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 numbers, UPCs & expiration codes

Lot #: 202364, Exp 5/28/2025

Where it was sold

USA Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0420-2025
Classification
Class II
Status
Ongoing
Recall initiated
May 2, 2025
FDA report date
May 21, 2025
Quantity
8,230 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Empower Clinic Services, LLC dba Empower Pharmacy

Original FDA data

Every field from FDA enforcement report D-0420-2025, exactly as published.

Show all FDA fields
City
Houston
State
TX
Status
Ongoing
Country
United States
Event ID
96808
Address
7601 N Sam Houston Pkwy W Ste 100
Code information
Lot #: 202364, Exp 5/28/2025
Postal code
77064-3595
Report date
May 21, 2025
Product type
Drugs
Recall number
D-0420-2025
Classification
Class II
Recalling firm
Empower Clinic Services, LLC dba Empower Pharmacy
Product quantity
8,230 vials
Reason for recall
Lack of Assurance of Sterility
Voluntary / mandated
Voluntary: Firm initiated
Product description
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.
Distribution pattern
USA Nationwide
Recall initiation date
May 2, 2025
Initial firm notification
E-Mail
Center classification date
May 9, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0420-2025, published May 21, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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