Why it was recalled
Marketed Without an Approved NDA/ANDA
Product description
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 numbers, UPCs & expiration codes
Lot P-24-1; Exp. 02/28/2027
Where it was sold
NY, NJ
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-0531-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 30, 2025
- FDA report date
- Jul 2, 2025
- Quantity
- 26 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Advanced Pharmaceutical Technology, Inc.
Original FDA data
Every field from FDA enforcement report D-0531-2025, exactly as published.
Show all FDA fields
- City
- Elmsford
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 96981
- Address
- 132 S Central Ave
- Code information
- Lot P-24-1; Exp. 02/28/2027
- Postal code
- 10523-3509
- Report date
- Jul 2, 2025
- Product type
- Drugs
- Recall number
- D-0531-2025
- Classification
- Class II
- Recalling firm
- Advanced Pharmaceutical Technology, Inc.
- Product quantity
- 26 vials
- Reason for recall
- Marketed Without an Approved NDA/ANDA
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- NY, NJ
- Recall initiation date
- May 30, 2025
- Initial firm notification
- Letter
- Center classification date
- Jul 16, 2025