Recalls / Class II
Class IID-0076-2025
Product
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17
- 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 #: D2300191, Exp 12/31/2025
Why it was recalled
Subpotent drug
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
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2024-11-08
- FDA classified
- 2024-11-29
- Posted by FDA
- 2024-12-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0076-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.