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.

FDA recall notice · announced June 18, 2025 · Macleods Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #: MLF2401A, Exp 01/31/2026
Quantity: 1,344- 1000 count bottles
Status: Ongoing
Products in this recall event:
- 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, Val (D-0470-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.