Levothyroxine Sodium Tablets — Class II drug recall D-0394-2025
Ongoing recall by ACCORD HEALTHCARE, INC., reported 2025-05-07, distributed nationwide. Subpotent
| Recall number | D-0394-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ACCORD HEALTHCARE, INC., Raleigh, NC, United States |
| Recall initiated | 2025-04-10 |
| Classified | 2025-04-30 |
| Reported by FDA | 2025-05-07 |
| Distributed | Nationwide (US) |
| Quantity | 4,888 bottles |
| Reason classes | potency |
| NDC | 16729-0447, 16729-0447-15, 16729-0447-17, 16729-0448, 16729-0448-15, 16729-0448-17, 16729-0449, 16729-0449-15, 16729-0449-17, 16729-0450, 16729-0450-15, 16729-0450-17, 16729-0451, 16729-0451-15, 16729-0451-17, 16729-0452, 16729-0452-15, 16729-0452-17, 16729-0453, 16729-0453-15, 16729-0453-17, 16729-0454, 16729-0454-15, 16729-0454-17, 16729-0455 and 11 more |
| Lot numbers | D2300323 |
| Expiration dates | 2026-01 |
Product
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-447-17
Reason for recall
Subpotent
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0394-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.