July 2025 FDA Recall Levoxyl by Pfizer
D-0575-2025 - Subpotent drug
This Class II drug recall was voluntarily initiated by Pfizer on July 29, 2025 for the product Levoxyl. The FDA reported the reason for recall as subpotent drug. The product was distributed in Within U.S and the recall is currently ongoing.
Recall Number: D-0575-2025
Subpotent drug
07-29-2025
08-20-2025
29, 004 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.
Pfizer
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.
Within U.S
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distributed by: Pfizer Inc., New York, NY 10017, Made in Austria, NDC 60793-851-01.
Batch or Lot Expiration Information
Lot# : 24C11, Exp 2/28/2026.
