Levothyroxine Sodium Tablets — Class III drug recall D-0470-2025
Ongoing recall by Macleods Pharmaceuticals Ltd, reported 2025-06-18, distributed nationwide. Presence of a foreign substance: black hair found embedded in tablet.
| Recall number | D-0470-2025 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Macleods Pharmaceuticals Ltd, Mumbai, India |
| Recall initiated | 2025-05-29 |
| Classified | 2025-06-12 |
| Reported by FDA | 2025-06-18 |
| Distributed | Nationwide (US) |
| Quantity | 1,344 |
| NDC | 33342-0393, 33342-0393-10, 33342-0393-11, 33342-0393-44, 33342-0394, 33342-0394-10, 33342-0394-11, 33342-0394-44, 33342-0395, 33342-0395-10, 33342-0395-11, 33342-0395-44, 33342-0396, 33342-0396-10, 33342-0396-11, 33342-0396-44, 33342-0397, 33342-0397-10, 33342-0397-11, 33342-0397-44, 33342-0398, 33342-0398-10, 33342-0398-11, 33342-0398-44, 33342-0399 and 23 more |
| Lot numbers | MLF2401A |
| Expiration dates | 2026-01-31 |
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 for recall
Presence of a foreign substance: black hair found embedded in tablet.
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-0470-2025. 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.