Reported Jul 29, 2026 · Ongoing · Updated Sep 16, 2026
Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of…
JB Chemicals and Pharmaceuticals Ltd.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: JB Chemicals and Pharmaceuticals Ltd · Neelam Centre A Wing A B Wing, 4th Floor; Hind Cycle Road · Mumbai
Is this the product you have?
Cetirizine Hydrochloride Tablets USP 5 mg100-count bottle
- Manufactured byUnique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India
- Distributed byRising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10
- Lot codes and dates
- Lots
GY825029GY825030GY825031GY825032
- expires2028-OCT
- Lots
- Amount recalled
- 34,020 100-count bottles.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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