Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle
Recalled by JB Chemicals and Pharmaceuticals Ltd
Class I — most serious
There is a reasonable chance that using this product could cause serious health problems or death.
JB Chemicals and Pharmaceuticals Ltd has recalled Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on July 29, 2026 and was initiated on June 24, 2026. It is classified as a Class I recall, which means there is a reasonable chance that using this product could cause serious health problems or death.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, with approximately 34,020 100-count bottles. affected. The company behind the recall is JB Chemicals and Pharmaceuticals Ltd, based in Mumbai, N/A. The FDA describes the product as: “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 1…”
Why was Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle recalled?
According to the FDA, the stated reason for the recall is: “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.”
What should you do?
If you think you may have bought Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, compare it against the product description and identifying codes (Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact JB Chemicals and Pharmaceuticals Ltd or your local health authority.
About this recall
This recall was distributed in N/A. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Who this recall affects
This recall matters to anyone who bought Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle. Even if you feel fine, it's worth checking what you have on hand rather than assuming you were missed.
Distribution listed in the notice: Nationwide in the USA.
How to check whether you have it
On medicine bottles, the lot number and expiration date are printed on the pharmacy label or stamped directly on the manufacturer's bottle — often near the bottom edge or on the back. If a pharmacy label covers it, your pharmacist can look up the lot they dispensed.
Compare what you find against the identifying details in this recall: Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT
What to do if you already bought it
Do not stop taking a prescribed medicine on your own because of a recall — for many conditions, an interrupted dose carries its own risk.
Instead, check the lot number against the details above and contact your pharmacist, who can confirm what they dispensed and arrange a replacement.
If you've had an unexpected reaction, contact your healthcare provider. Problems can also be reported to the FDA's MedWatch program.
Full recall details
- Status
- Ongoing
- Date reported
- July 29, 2026
- Recall started
- June 24, 2026
- Distributed in
- N/A
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle recalled?+
According to the FDA: Cross Contamination with Other Products: Customer complaints for appearance of discolored tablet…
How serious is this recall?+
Class I — most serious. There is a reasonable chance that using this product could cause serious health problems or death.
What should I do if I have Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0732-2026. Information last synced from the FDA on August 19, 2026.