FDA Recall Database: Class I Recall: CETIRIZINE HYDROCHLORIDE by JB Chemicals and Pharmaceuticals Ltd

Key facts

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of 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. should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from JB Chemicals and Pharmaceuticals Ltd. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from JB Chemicals and Pharmaceuticals Ltd should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to JB Chemicals and Pharmaceuticals Ltd directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

What this classification means

A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class I, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

JB Chemicals and Pharmaceuticals Ltd’s FDA history

Argus HQ has recorded 2 total FDA actions tied to JB Chemicals and Pharmaceuticals Ltd: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Why was Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, recalled?

FDA's recall record states the reason as: 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.

Who should I contact about this recall?

Contact JB Chemicals and Pharmaceuticals Ltd directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.

Has JB Chemicals and Pharmaceuticals Ltd had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 2 total FDA actions tied to JB Chemicals and Pharmaceuticals Ltd, including 2 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number D-0732-2026.

Related enforcement actions