Cetirizine Hydrochloride Tablet
FDA Recall NDC 16571-401
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 Cetirizine Hydrochloride (NDC 16571-401). A significant event, classified as Class I, was initiated on Jun 24, 2026 by Rising Pharma Holdings, Inc.. The reported reason for this action was: "Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine."
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 I Ongoing
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Jun 24, 2026
Jul 29, 2026
34,020 100-count bottles.
Recall Profile & Regulatory Data
Event ID
99321
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
JB Chemicals and Pharmaceuticals Ltd
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10.
Batch or Lot Expiration Information
Lot# Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT
Affected Packages Involved in this Recall
16571-401-10Product
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.
