Recalls / Class II
Class IID-0006-2026
Product
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15.
- 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 # D2300045, Exp 12/31/2025.
Why it was recalled
Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Recalling firm
- Firm
- ACCORD HEALTHCARE, INC.
- Manufacturer
- Accord Healthcare Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8041 Arco Corporate Dr Ste 200, Raleigh, North Carolina 27617-2010
Distribution
- Quantity
- 54,432 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2025-09-16
- FDA classified
- 2025-10-06
- Posted by FDA
- 2025-10-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0006-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.