FDA recall D-0470-2025

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.

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2025-05-29

Report date

2025-06-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mumbai, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0470-2025