Cetirizine Hydrochloride Tablets USP 5 mg recall
FDA recall D-0732-2026 · initiated Jun 24, 2026
JB Chemicals and Pharmaceuticals Ltd recalled Cetirizine Hydrochloride Tablets USP 5 mg in Jun 2026 — an FDA Class I recall (D-0732-2026) because Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
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: 34,020 100-count bottles.
Details
- Product
- Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, 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 16571-401-10.
- Recalling company
- JB Chemicals and Pharmaceuticals Ltd
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jun 24, 2026
- FDA report date
- Jul 29, 2026
Frequently asked
- Was Cetirizine Hydrochloride Tablets USP 5 mg recalled?
- JB Chemicals and Pharmaceuticals Ltd recalled Cetirizine Hydrochloride Tablets USP 5 mg in Jun 2026 — an FDA Class I recall (D-0732-2026) because Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Cetirizine Hydrochloride Tablets USP 5 mg recalled?
- Per the FDA enforcement record, the reason for recall D-0732-2026 was: Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
- Is a recalled Cetirizine Hydrochloride Tablets USP 5 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. Most serious — a reasonable probability that use will cause serious harm or death. 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 5 mg are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lots: GY825029, GY825030, GY825031, GY825032, expires: 2028-OCT. 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-0732-2026.