Cetirizine Hydrochloride Tablets USP 5 mg recall (JB Chemicals and Pharmaceuticals Ltd)
DrugClass IOngoing
Summary: JB Chemicals and Pharmaceuticals Ltd is recalling 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.. 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.
What is being recalled
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.
Why
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.
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
Nationwide in the USA
How to tell if yours is affected
Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0732-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | June 24, 2026 |
| Reported | July 29, 2026 |
| Company | JB Chemicals and Pharmaceuticals Ltd |
| Company location | Mumbai, N/A, India |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 34,020 100-count bottles. |
More recalls from JB Chemicals and Pharmaceuticals Ltd · all drug recalls · recalls from June 2026