Cetirizine Hydrochloride Tablets USP 10 mg recall
FDA recall D-0033-2026 · initiated Sep 12, 2025
JB Chemicals and Pharmaceuticals Ltd recalled Cetirizine Hydrochloride Tablets USP 10 mg in Sep 2025 — an FDA Class III recall (D-0033-2026) because Tablet/Capsules Imprinted with Wrong ID.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Tablet/Capsules Imprinted with Wrong ID
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 13,440 bottles
Details
- 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
- Recalling company
- JB Chemicals and Pharmaceuticals Ltd
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- Sep 12, 2025
- FDA report date
- Oct 29, 2025
Frequently asked
- Was Cetirizine Hydrochloride Tablets USP 10 mg recalled?
- JB Chemicals and Pharmaceuticals Ltd recalled Cetirizine Hydrochloride Tablets USP 10 mg in Sep 2025 — an FDA Class III recall (D-0033-2026) because Tablet/Capsules Imprinted with Wrong ID. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Cetirizine Hydrochloride Tablets USP 10 mg recalled?
- Per the FDA enforcement record, the reason for recall D-0033-2026 was: Tablet/Capsules Imprinted with Wrong ID
- Is a recalled Cetirizine Hydrochloride Tablets USP 10 mg dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Cetirizine Hydrochloride Tablets USP 10 mg are affected?
- Distributed: U.S. Nationwide. The recall covers these lots — Lot # PY925014, PY925013, Exp. 1/31/2028. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0033-2026.