Recalls / Class III
Class IIID-0033-2026
Product
Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, 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 16571-402-50
- Brand name
- Cetirizine Hydrochloride
- Generic name
- Cetirizine Hydrochloride
- Active ingredient
- Cetirizine Hydrochloride
- Route
- Oral
- NDC
- 16571-402
- FDA application
- ANDA077829
- Affected lot / code info
- Lot # PY925014, PY925013, Exp. 1/31/2028
Why it was recalled
Tablet/Capsules Imprinted with Wrong ID
Recalling firm
- Firm
- JB Chemicals and Pharmaceuticals Ltd
- Manufacturer
- Rising Pharma Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Neelam Centre A Wing A B Wing, 4th Floor; Hind Cycle Road, Mumbai, N/A, India
Distribution
- Quantity
- 13,440 bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2025-09-12
- FDA classified
- 2025-10-17
- Posted by FDA
- 2025-10-29
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0033-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.