FDA Recall D-0032-2026

JB Chemicals and Pharmaceuticals Ltd

Class III Ongoing 244 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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.

Lot / code: Lot # PY925014A; Exp. 1/31/2028

Quantity: 9936 bottles

Reason for recall

Tablet/Capsules Imprinted with Wrong ID

Recall record

Recall number: D-0032-2026
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S. Nationwide
Recall initiated: 2025-09-12
Classified by FDA Center: 2025-10-17
FDA published: 2025-10-29
Recalling firm: JB Chemicals and Pharmaceuticals Ltd

Drug identification

Brand name(s): CETIRIZINE HYDROCHLORIDE
Generic name(s): CETIRIZINE HYDROCHLORIDE
Manufacturer(s): Rising Pharma Holdings, Inc.
NDC(s): 16571-402
Route(s): ORAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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