Recalls / Class II
Class IID-0524-2025
Product
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 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 16729-456-17
- Brand name
- Levothyroxine Sodium
- Generic name
- Levothyroxine Sodium
- Active ingredient
- Levothyroxine Sodium
- Route
- Oral
- NDCs
- 16729-447, 16729-458, 16729-448, 16729-449, 16729-451, 16729-450, 16729-452, 16729-453, 16729-454, 16729-455 +2 more
- FDA application
- ANDA212399
- Affected lot / code info
- Lot #D2300042, Exp Date: 12/31/2025
Why it was recalled
Subpotent Drug: Assay below the approved specification
Recalling firm
- Firm
- ACCORD HEALTHCARE, INC.
- Manufacturer
- Accord Healthcare Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8041 Arco Corporate Dr Ste 200, N/A, Raleigh, North Carolina 27617-2010
Distribution
- Quantity
- 2,344 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-06-20
- FDA classified
- 2025-07-14
- Posted by FDA
- 2025-07-23
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0524-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.