June 2026 FDA Recall Cetirizine Hydrochloride by Jb Chemicals And Pharmaceuticals Ltd
D-0732-2026 - Cross Contamination with Other Products
This Class I drug recall was voluntarily initiated by Jb Chemicals And Pharmaceuticals Ltd on June 24, 2026 for the product Cetirizine Hydrochloride. The FDA reported the reason for recall as cross contamination with other products. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0732-2026
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.
06-24-2026
07-29-2026
34,020 100-count bottles.
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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.
JB Chemicals and Pharmaceuticals Ltd
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.
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
