Levothyroxine Sodium Tablets — Class II drug recall D-0006-2026
Ongoing recall by ACCORD HEALTHCARE, INC., reported 2025-10-15, distributed nationwide. Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay conten
| Recall number | D-0006-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ACCORD HEALTHCARE, INC., Raleigh, NC, United States |
| Recall initiated | 2025-09-16 |
| Classified | 2025-10-06 |
| Reported by FDA | 2025-10-15 |
| Distributed | Nationwide (US) |
| Quantity | 54,432 bottles |
| Reason classes | potency, specification failure |
| 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 | D2300045 |
| Expiration dates | 2025-12-31 |
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.
Reason for recall
Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
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-0006-2026. 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.