Why it was recalled
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Product description
Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Lot numbers, UPCs & expiration codes
Lot #: 25149, Exp. Date: 04/30/2027; 25371, Exp. Date: 09/30/2027.
Where it was sold
Nationwide within the U.S
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-0801-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 24, 2026
- FDA report date
- Aug 26, 2026
- Quantity
- 323,000 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Regent, Inc.
Original FDA data
Every field from FDA enforcement report D-0801-2026, exactly as published.
Show all FDA fields
- City
- Shirley
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 99503
- Address
- 5 Ramsay Rd
- Code information
- Lot #: 25149, Exp. Date: 04/30/2027; 25371, Exp. Date: 09/30/2027.
- Postal code
- 11967-4701
- Report date
- Aug 26, 2026
- Product type
- Drugs
- Recall number
- D-0801-2026
- Classification
- Class II
- Recalling firm
- American Regent, Inc.
- Product quantity
- 323,000 vials
- Reason for recall
- Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
- Distribution pattern
- Nationwide within the U.S
- Recall initiation date
- Jul 24, 2026
- Initial firm notification
- Press Release
- Center classification date
- Aug 26, 2026