FDA Drugs recall ·
Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles… recall
- Recall number
- D-0032-2026
- Date
- (initiated September 12, 2025)
- Company / brand
- JB Chemicals and Pharmaceuticals Ltd
Neelam Centre A Wing A B Wing, Mumbai, India - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 9936 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Cetirizine Hydrochloride Tablets USP 10 mg, 100 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 16571-402-10.
Why was it recalled?
Tablet/Capsules Imprinted with Wrong ID
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
Lot # PY925014A; Exp. 1/31/2028
Distribution
U.S. Nationwide
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0032-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.