Why it was recalled
Subpotent Drug: Assay below the approved specification
Product description
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-451-17
Lot numbers, UPCs & expiration codes
Lot #D2300092, Exp Date: 12/31/2025; Lot #D2400722, Exp Date: 03/31/2026
Where it was sold
Nationwide in the USA
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-0521-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 20, 2025
- FDA report date
- Jul 23, 2025
- Quantity
- 9,739 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ACCORD HEALTHCARE, INC.
Original FDA data
Every field from FDA enforcement report D-0521-2025, exactly as published.
Show all FDA fields
- City
- Raleigh
- State
- NC
- Status
- Ongoing
- Country
- United States
- Event ID
- 97103
- Address
- 8041 Arco Corporate Dr Ste 200
- Code information
- Lot #D2300092, Exp Date: 12/31/2025; Lot #D2400722, Exp Date: 03/31/2026
- Postal code
- 27617-2010
- Report date
- Jul 23, 2025
- Product type
- Drugs
- Recall number
- D-0521-2025
- Classification
- Class II
- Recalling firm
- ACCORD HEALTHCARE, INC.
- Product quantity
- 9,739 bottles
- Reason for recall
- Subpotent Drug: Assay below the approved specification
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-451-17
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 20, 2025
- Initial firm notification
- Letter
- Center classification date
- Jul 14, 2025