February 2026 FDA Recall Levothyroxine Sodium by Macleods Pharma Usa, Inc
D-0403-2026 - Subpotent Drug
This Class II drug recall was voluntarily initiated by Macleods Pharma Usa, Inc on February 26, 2026 for the product Levothyroxine Sodium. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0403-2026
Subpotent Drug
02-26-2026
04-01-2026
1315 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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 PHARMA USA, INC
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
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44
Batch or Lot Expiration Information
Lot# Lot 16240062A, exp date 3/2026
