June 2026 FDA Recall Hydroxyzine Hydrochloride by Ani Pharmaceuticals, Inc.
D-0619-2026 - Presence of foreign substance
This Class III drug recall was voluntarily initiated by Ani Pharmaceuticals, Inc. on June 2, 2026 for the product Hydroxyzine Hydrochloride. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0619-2026
Presence of foreign substance
06-02-2026
07-01-2026
6564 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.
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.
hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10
Batch or Lot Expiration Information
Lot# Lot S25133A
