Hydroxyzine Hydrochloride Solution
FDA Recall NDC 70954-912
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Hydroxyzine Hydrochloride (NDC 70954-912). A significant event, classified as Class III, was initiated on Jun 02, 2026 by Ani Pharmaceuticals, Inc.. The reported reason for this action was: "Presence of foreign substance"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Presence of foreign substance
Jun 02, 2026
Jul 01, 2026
6564 bottles
Recall Profile & Regulatory Data
Event ID
99131
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
ANI Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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
Affected Packages Involved in this Recall
70954-912-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
