FDA Recall D-0470-2025
Macleods Pharmaceuticals Ltd
Class III Ongoing 350 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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.
Recall record
- Recall number
D-0470-2025- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2025-05-29
- Classified by FDA Center
- 2025-06-12
- FDA published
- 2025-06-18
- Recalling firm
- Macleods Pharmaceuticals Ltd
Drug identification
- Brand name(s)
- LEVOTHYROXINE SODIUM
- Generic name(s)
- LEVOTHYROXINE SODIUM
- Manufacturer(s)
- Macleods Pharmaceuticals Limited
- NDC(s)
33342-393, 33342-394, 33342-395, 33342-396, 33342-397, 33342-398, 33342-399, 33342-400, 33342-401, 33342-402, 33342-403, 33342-404- Route(s)
- ORAL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.