FDA Drugs recall ·
Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0732-2026
- Date
- (initiated June 24, 2026)
- Company / brand
- JB Chemicals and Pharmaceuticals Ltd
Neelam Centre A Wing A B Wing, Mumbai, N/A, India - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 34,020 100-count bottles.
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT
Distribution
Nationwide in the USA
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0732-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.