Reported Oct 29, 2025 · Ongoing
Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div.…
JB Chemicals and Pharmaceuticals Ltd.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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 · Mumbai · N/A
Is this the product you have?
Cetirizine Hydrochloride Tablets USP 10 mg500 Tablets bottles
- 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 16571-402-50
- Lot codes and dates
Lot # PY925014PY925013Exp. 1/31/2028
- Amount recalled
- 13,440 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Tablet/Capsules Imprinted with Wrong ID
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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