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FDA recall announcement

Cetirizine recall 2026

Four lots of cetirizine hydrochloride 5 mg tablets were voluntarily recalled to the consumer level after potential cross contamination with ranitidine.

A specific recall was announced.

Potential cross contamination with ranitidine.

FDA publish date
July 20, 2026
Company
Unique Pharmaceutical Laboratories
Product
Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle
Last checked
September 23, 2026
NDC / identifier
16571-401-10
Affected lot(s)
GY825029, GY825030, GY825031, GY825032

What the FDA announcement says

Potential cross contamination with ranitidine.

Read the original FDA cetirizine recall announcement →

What to check on the package

  1. Confirm the exact product and brand name.
  2. Compare the manufacturer or distributor.
  3. Match the NDC or product identifier.
  4. Match the lot or code exactly; a drug name alone is not enough.

Listed expiration date(s): October 2028

What to do

Check the NDC and lot on the bottle. Contact the dispensing pharmacy or Rising Pharma if they match. Contact a healthcare professional about any suspected reaction.

Do not stop or change a prescribed medication based only on this page. Contact a pharmacist, prescriber, or the recalling company for instructions specific to your product.

Related FDA enforcement records

4 matching records appear in the current 24-month openFDA snapshot. Use the search tool to compare the exact manufacturer, NDC, and lot.

Search all records for Cetirizine →

Source and limitations

This server-rendered page summarizes an FDA source and the openFDA enforcement snapshot last checked on September 23, 2026. It is not an FDA service and does not provide individual medical advice.