JB Chemicals recalls Cetirizine Hydrochloride 10 mg tablets because tablets carry the wrong ID imprint
The cetirizine tablets were stamped with the wrong identification imprint, so the markings on the tablets do not match what they should show.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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.; Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of…
- Hazard
- Tablet/Capsules Imprinted with Wrong ID
- Units
- 9936 bottles; 13,440 bottles
- Where sold
- U.S. Nationwide
- FDA classification
- Class III · Ongoing
- Classified by FDA
- October 17, 2025
- Recall started
- September 12, 2025
- FDA enforcement report
- October 29, 2025
- Identifiers
- Codes: Lot # PY925014A; Exp. 1/31/2028
- FDA recall number: D-0032-2026
- Codes: Lot # PY925014, PY925013, Exp. 1/31/2028
- FDA recall number: D-0033-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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. | 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
- Reason for recall
- Tablet/Capsules Imprinted with Wrong ID
- Classification
- Class III (Ongoing)
- Distribution
- U.S. Nationwide
- Quantity
- 9936 bottles; 13,440 bottles
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