FDA Drug recall D-0470-2025
Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc
- FDA Drug
- Class III
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class III recall of Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc by Macleods Pharmaceuticals, citing presence of a foreign substance: black hair found embedded in tablet.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0470-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-05-29 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Macleods Pharmaceuticals |
| Distribution | US |
Product
Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540. Manufactured by: Macleods Pharmaceuticals Ltd. Sarigam, Valsad, Gujarat, India, NDC 33342-398-44.
Reason
Presence of a foreign substance: black hair found embedded in tablet.
Identifiers
| ndc | 33342-393-10 |
|---|---|
| ndc | 33342-393-11 |
| ndc | 33342-393-44 |
| ndc | 33342-394-10 |
| ndc | 33342-394-11 |
| ndc | 33342-394-44 |
| ndc | 33342-395-10 |
| ndc | 33342-395-11 |
| ndc | 33342-395-44 |
| ndc | 33342-396-10 |
| ndc | 33342-396-11 |
| ndc | 33342-396-44 |
| ndc | 33342-397-10 |
| ndc | 33342-397-11 |
| ndc | 33342-397-44 |
| ndc | 33342-398-10 |
| ndc | 33342-398-11 |
| ndc | 33342-398-44 |
| ndc | 33342-399-10 |
| ndc | 33342-399-11 |
| ndc | 33342-399-44 |
| ndc | 33342-400-10 |
| ndc | 33342-400-11 |
| ndc | 33342-400-44 |
| ndc | 33342-401-10 |
| ndc | 33342-401-11 |
| ndc | 33342-401-44 |
| ndc | 33342-402-10 |
| ndc | 33342-402-11 |
| ndc | 33342-402-44 |
| ndc | 33342-403-10 |
| ndc | 33342-403-11 |
| ndc | 33342-403-44 |
| ndc | 33342-404-10 |
| ndc | 33342-404-11 |
| ndc | 33342-404-44 |
| code_info | Lot #: MLF2401A, Exp 01/31/2026 |
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-0470-2025%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.