FDA recall, , High risk
Rising Pharma Cetirizine Hydrochloride Tablets
Cetirizine Hydrochloride Tablets may be contaminated with ranitidine, which could cause serious reactions.
Summary by Recall Canary from the FDA notice
What happened
Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) is voluntarily recalling four lots of Cetirizine Hydrochloride Tablets USP 5 mg to the consumer level due to cross contamination with Ranitidine. The recall began on June 24, 2026, was announced on July 18, 2026, and was added to the FDA's Enforcement Report on July 23, 2026. The product is distributed by Rising Pharma Holdings, Inc., East Brunswick, NJ, nationwide in the USA.
The contamination was determined after customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. The product is manufactured by Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. The recall was classified by the FDA on August 3, 2026.
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What to do
If a code on your package is listed below:
- Consumers with general or medical inquiries regarding this recall can contact Rising Pharma Holdings Inc. at: Phone number: 1-844-874-7464 8:00 a.m. to 5:00 p.m. (EST), (Monday-Friday) or e-mail address: pv@
risingpharma.com or qa@ risingpharma.com. - Contact your physician or healthcare provider if you have experienced any problems that may be related to taking or using this drug product.
Is your container affected?
Match the lot code, best-by or expiration date and NDC listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Cetirizine Hydrochloride Tablets USP 5 mg, Pack 100’s HDPE container
- NDC
- 16571-401-10
- Lot code
- GY825029
- GY825030
- GY825031
- GY825032
- Best-by or expiration date
- 10/2028
- Distribution
- Rising Pharma Holdings Inc.
- Manufacturer
- Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.)
Recall details
- Company began the recall
- Sold in
Nationwide in the USA
- Company
- JB Chemicals and Pharmaceuticals LtdMumbai, India
- Hazard
- Contamination
- Risk
High risk
There is a reasonable chance that taking it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 99321
- Recall number
- D-0732-2026
All recalls from JB Chemicals and Pharmaceuticals Ltd
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Announced by the company
Listed on Recall Canary
Added to FDA's Enforcement Report
In FDA's weekly enforcement report
Classified by FDA
Summary updated
