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Class IOngoing

JB Chemicals and Pharmaceuticals Ltd recalls Cetirizine Hydrochloride Tablets USP 5 mg

Recall date · record updated Jul 29, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
JB Chemicals and Pharmaceuticals Ltd
Reason
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.
Hazard
FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).
Who’s affected
Nationwide in the USA
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99321…

Products

  1. 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.

    Codes/lots: Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCTQuantity: 34,020 100-count bottles.Recall no. D-0732-2026Class I

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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