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FDA Recalls Cetirizine Tablets Over Ranitidine Contamination Risk

7/22/2026

Summary

Story summary

The FDA announced a recall of four lots of 5-mg cetirizine tablets because of possible ranitidine cross-contamination.
Unique Pharmaceutical Laboratories, a J.B. Chemicals & Pharmaceuticals Ltd. division, produced the recalled lots GY825029-032 in 100-tablet bottles expiring 10/2028.
A pharmacy technician spotted a red dot on the tablets, leading to the recall.
The FDA warned that ranitidine-sensitive users could experience anaphylaxis or other severe reactions.

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Story summary

The FDA announced a recall of four lots of 5-mg cetirizine tablets because of possible ranitidine cross-contamination.
Unique Pharmaceutical Laboratories, a J.B. Chemicals & Pharmaceuticals Ltd. division, produced the recalled lots GY825029-032 in 100-tablet bottles expiring 10/2028.
A pharmacy technician spotted a red dot on the tablets, leading to the recall.
The FDA warned that ranitidine-sensitive users could experience anaphylaxis or other severe reactions.