Cetirizine Hydrochloride Tablets USP 5 mg

  • Potential cross contamination with Ranitidine
  • Company: Unique Pharmaceutical Laboratories
  • Drugs
  • FDA
  • July 18, 2026

Product details

  • Cetirizine Hydrochloride Tablets USP 5 mg

Company announcement

Unique Pharmaceutical Laboratories is voluntarily recalling four lots of Cetirizine Hydrochloride Tablets USP 5 mg due to potential cross-contamination with Ranitidine.

The affected product was distributed nationwide to several wholesalers/retailers.

To date, no adverse events related to this recall have been reported as of July 18, 2026.

Risk:

For consumers with a hypersensitivity to the ingredients in ranitidine, there is a reasonable probability that ingestion of Cetirizine tablets contaminated with ranitidine could result in serious adverse events including severe hypersensitivity reactions and anaphylaxis that manifests as hypotension, dyspnea, difficulty swallowing, throat and facial edema, generalized pruritic, urticaria, and loss of consciousness, which are all life-threatening. To date, Unique Pharmaceuticals has not received any reports of adverse events related to this recall.

Impacted states: Nationwide

Products:

- Cetirizine Hydrochloride Tablets USP 5 mg

Contact

For more information, call 1-844-874-7464 or email pv@risingpharma.com or qa@risingpharma.com.

View the original FDA notice

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