May 2025 FDA Recall Levothyroxine Sodium by Macleods Pharmaceuticals Ltd
D-0470-2025 - Presence of a foreign substance
This Class III drug recall was voluntarily initiated by Macleods Pharmaceuticals Ltd on May 29, 2025 for the product Levothyroxine Sodium. The FDA reported the reason for recall as presence of a foreign substance. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0470-2025
Presence of a foreign substance: black hair found embedded in tablet.
05-29-2025
06-18-2025
1,344- 1000 count bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Macleods Pharmaceuticals Ltd
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of 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.
Batch or Lot Expiration Information
Lot# : MLF2401A, Exp 01/31/2026
