May 2026 FDA Recall Estradiol by Ani Pharmaceuticals, Inc.
D-0543-2026 - Defective Container; packets were found to be either empty or partially full.
This Class II drug recall was voluntarily initiated by Ani Pharmaceuticals, Inc. on May 12, 2026 for the product Estradiol. The FDA reported the reason for recall as defective container; packets were found to be either empty or partially full.. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0543-2026
Defective Container; packets were found to be either empty or partially full.
05-12-2026
05-27-2026
3964 Cartons
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.
ANI Pharmaceuticals, 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 in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20
Batch or Lot Expiration Information
Lot# Lot M251109, exp Nov 2027
