FDA Drug recall D-0396-2025
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, M…
- FDA Drug
- Class II
- ongoing
- Published 2025-05-07
On 2025-05-07 the FDA classified a Class II recall of Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, M… by Accord Healthcare, citing subpotent.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0396-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-10 |
| Published | 2025-05-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Accord Healthcare |
| Distribution | US |
Product
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 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 16729-450-17
Reason
Subpotent
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 # D2300044, Exp Date: 12/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Accord Healthcare
- Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 2…
FDA Drug · Class II · 2026-09-02 · Accord Healthcare - Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 2…
FDA Drug · Class II · 2026-09-02 · Accord Healthcare - Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-count bottles, (NDC 167…
FDA Drug · Class II · 2026-09-02 · Accord Healthcare - Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 1…
FDA Drug · Class II · 2026-09-02 · Accord Healthcare - Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 2761…
FDA Drug · Class II · 2026-09-02 · Accord Healthcare
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0396-2025%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.