← FDA ENFORCEMENT
D-0033-2026Class III

JB Chemicals and Pharmaceuticals Ltd

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
JB Chemicals and Pharmaceuticals Ltd
Product type
Drug
Status
Ongoing
Report date
2025-10-29
Distribution
U.S. Nationwide
Product quantity
13,440 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall

Tablet/Capsules Imprinted with Wrong ID

Product description

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

Code / lot info

Lot # PY925014, PY925013, Exp. 1/31/2028

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →