D-0033-2026Class III

JB Chemicals and Pharmaceuticals Ltd

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2025-10-29

Distribution

U.S. Nationwide

Product quantity

13,440 bottles

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

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

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Data: U.S. FDA openFDA enforcement API. 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.