FDA Recall D-0076-2025
ACCORD HEALTHCARE, INC. · Raleigh, NC
Class II Ongoing 552 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
Subpotent drug
Recall record
- Recall number
D-0076-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- USA Nationwide
- Recall initiated
- 2024-11-08
- Classified by FDA Center
- 2024-11-29
- FDA published
- 2024-12-11
- Recalling firm
- ACCORD HEALTHCARE, INC.
- Firm location
- Raleigh, NC
Drug identification
- Brand name(s)
- LEVOTHYROXINE SODIUM
- Generic name(s)
- LEVOTHYROXINE SODIUM
- Manufacturer(s)
- Accord Healthcare Inc.
- NDC(s)
16729-447, 16729-458, 16729-448, 16729-449, 16729-451, 16729-450, 16729-452, 16729-453, 16729-454, 16729-455, 16729-456, 16729-457- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.