FDA Drug recall D-0006-2026
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC…
- FDA Drug
- Class II
- ongoing
- Published 2025-10-15
On 2025-10-15 the FDA classified a Class II recall of Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC… by Accord Healthcare, citing subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0006-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-16 |
| Published | 2025-10-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Accord Healthcare |
| Distribution | US |
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
Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Identifiers
| ndc | 16729-458-15 |
|---|---|
| ndc | 16729-458-17 |
| ndc | 16729-447-15 |
| ndc | 16729-447-17 |
| ndc | 16729-448-15 |
| ndc | 16729-448-17 |
| ndc | 16729-449-15 |
| ndc | 16729-449-17 |
| ndc | 16729-451-15 |
| ndc | 16729-451-17 |
| ndc | 16729-450-15 |
| ndc | 16729-450-17 |
| ndc | 16729-452-15 |
| ndc | 16729-452-17 |
| ndc | 16729-453-15 |
| ndc | 16729-453-17 |
| ndc | 16729-454-15 |
| ndc | 16729-454-17 |
| ndc | 16729-455-15 |
| ndc | 16729-455-17 |
| ndc | 16729-456-15 |
| ndc | 16729-456-17 |
| ndc | 16729-457-15 |
| ndc | 16729-457-17 |
| code_info | Lot # D2300045, Exp 12/31/2025. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0006-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.