JB Chemicals and Pharmaceuticals Ltd drug recall: Cetirizine Hydrochloride Tablets USP 5 mg
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 99321
- Recall initiated
- Jun 24, 2026
- Classified by FDA
- Aug 3, 2026
- Posted in Enforcement Report
- Jul 29, 2026
- Recalling firm
- JB Chemicals and Pharmaceuticals Ltd
- Firm location
- Mumbai, India
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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 the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Jun 24, 2026. FDA classified it 40 days later, on Aug 3, 2026. Distribution reported by FDA: Nationwide in the USA JB Chemicals and Pharmaceuticals Ltd has 3 recalls in our records.
Recalled products (1)
D-0732-2026 Class I Ongoing
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.
Codes / lots: Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT
Quantity: 34,020 100-count bottles.
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
- Official notice
- FDA Enforcement Report, event 99321
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.