What happened
Check for Rising Pharma cetirizine hydrochloride tablets USP 5 mg in a 100-count bottle with NDC 16571-401-10. The recalled lots are GY825029, GY825030, GY825031 and GY825032, all with an October 2028 expiration date. Contact the distributor or a healthcare professional rather than discarding or changing medication based only on a headline.
Exactly which bottles are recalled
Unique Pharmaceutical Laboratories voluntarily recalled four lots distributed by Rising Pharma Holdings. The FDA-posted announcement identifies 5 mg cetirizine tablets in 100-count HDPE bottles, NDC 16571-401-10. The four affected lots are GY825029 through GY825032, with expiration 10/2028. Other strengths, package sizes, manufacturers and lots are not named in this announcement.
Why the company recalled them
The announcement cites potential cross-contamination with ranitidine after a pharmacy technician reported tablets with red dots and discoloration. The stated risk is particularly serious for people hypersensitive to ranitidine ingredients because exposure could cause severe allergic reactions. The company said it had received no reports of adverse events related to the recall as of the announcement.
What consumers can do
Compare the NDC and lot number on the original bottle or pharmacy label with the FDA notice and product photos. Rising Pharma lists a consumer contact number and email in the announcement and is arranging returns through distributors. Anyone who experienced a problem that may be related to the product should contact a healthcare professional and can report it through the FDA’s MedWatch system.
Reporting used for this story
- Nationwide recall of cetirizine hydrochloride tablets USP 5 mgU.S. Food and Drug Administration · 2026-07-20
- FDA drug recallsU.S. Food and Drug Administration · 2026-07-30
- FDA warning about severe itching after stopping long-term cetirizineU.S. Food and Drug Administration · 2025-05-16
This unpublished draft uses an ethical-curiosity headline: the article must answer the headline promptly, preserve uncertainty and remain source-linked after human review.