Multi-event September 2025 FDA Recall Cetirizine Hydrochloride by Jb Chemicals And Pharmaceuticals Ltd
This Multi-event Class III drug recall was voluntarily initiated by Jb Chemicals And Pharmaceuticals Ltd on September 12, 2025 for the product Cetirizine Hydrochloride. The FDA reported the reason for recall as tablet/capsules imprinted with wrong id. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0032-2026
Tablet/Capsules Imprinted with Wrong ID
09-12-2025
10-29-2025
9936 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.
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.
U.S. Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, 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 16571-402-10.
Batch or Lot Expiration Information
Lot# PY925014A; Exp. 1/31/2028
Affected Packages Involved in this Recall
Recall Number: D-0033-2026
Tablet/Capsules Imprinted with Wrong ID
09-12-2025
10-29-2025
13,440 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.
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.
U.S. Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, 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 16571-402-50
Batch or Lot Expiration Information
Lot# PY925014, PY925013, Exp. 1/31/2028
