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 0881

FDA recall notice · announced October 29, 2025 · Jb Chemicals And Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Reason for recall

Tablet/Capsules Imprinted with Wrong ID

Notes

Distribution: U.S. Nationwide
Lot/code information: Lot # PY925014A; Exp. 1/31/2028
Quantity: 9936 bottles
Status: Ongoing
Products in this recall event:
- 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 (D-0033-2026)
- 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 (D-0032-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.