FDAFDA recall D-0732-2026 · Jul 29, 2026
JB Chemicals and Pharmaceuticals Ltd: Cetirizine Hydrochloride Tablets USP 5 mg recall
Recall found
Product
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 for recall
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 to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
- Status
- Ongoing
- Codes, lots and dates
- Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT
- Quantity
- 34,020 100-count bottles.
- Distribution
- Nationwide in the USA
- Recalling firm
- JB Chemicals and Pharmaceuticals Ltd, Mumbai, N/A
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-24
Source: openFDA enforcement record D-0732-2026 · search recall number D-0732-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.