Accessing allergy medication should be routine, not something you need to check again. But if you’re taking generic cetirizine (the active ingredient in Zyrtec), it’s worth looking at your bottle before your next dose — four specific batches have just been recalled from across the country due to a risk of contamination that the FDA describes as potentially life-threatening.
Key takeaways
- Unique Pharmaceutical Laboratories has voluntarily recalled four batches of Cetirizine Hydrochloride USP 5 mg tablets, which were distributed nationwide by Rising Pharma Holdings, after they were found to be contaminated with a different drug, ranitidine.
- People who are allergic to ranitidine may experience severe allergic reactions, including a dangerous drop in blood pressure, swelling of the throat and face, difficulty breathing, hives, or loss of consciousness – the FDA describes these symptoms as potentially life-threatening.
- No adverse events have been reported to date in connection with this recall.
- This problem was discovered by a pharmacy technician who noticed red dots and discoloration on some of the tablets while they were being counted for dispensing.
What was actually remembered
The recall covers Cetirizine Hydrochloride USP 5 mg tablets, which are sold in 100-tablet bottles under NDC 16571-401-10, are manufactured by Unique Pharmaceutical Laboratories (a division of JB Chemicals & Pharmaceuticals) and distributed by Rising Pharma Holdings. Four specific lots are affected, all of which share the same expiration date:
- Batch GY825029 – Expires 10/2028
- Batch GY825030 – Expires 10/2028
- Batch GY825031 – Expires 10/2028
- Batch GY825032 – Expires 10/2028
The batch number is printed on the bottle label, along with the NDC number – both of which are worth checking this list if you have a bottle of generic cetirizine at home.
Why is this a serious risk?
The tablets were cross-contaminated with ranitidine, a different drug that was widely used to treat ulcers and acid reflux (sold under the brand name Zantac before it was pulled from the market in 2020 due to an unrelated contamination issue). Cetirizine and ranitidine are two completely different classes of medications, so a person taking allergy pills has no reason to expect — or watch for — a reaction associated with a completely different drug. The FDA’s risk statement is explicit about the risks: People with hypersensitivity to ranitidine can experience severe allergic reactions or anaphylaxis, with symptoms including low blood pressure, difficulty breathing or swallowing, swelling of the throat and face, hives, and loss of consciousness — all of which the agency classifies as potentially life-threatening. As of the recall announcement, no adverse events associated with this contamination have been reported.
How was the problem found?
According to the company’s recall notice, a pharmacy technician noticed something while counting pills for a prescription: Some pills had unusual red dots on them, while others appeared discolored. This discrepancy led to a product complaint, which led to cross-contamination with ranitidine. It’s a useful reminder that inspecting tablets visually – not just trusting the label – sometimes reveals issues that automated quality checks miss.
What to do if you have this product
If you have a bottle of generic cetirizine at home, check the NDC number (16571-401-10) and lot number against the list above. If it matches, stop taking it and contact Rising Pharma Holdings at 1-844-874-7464 (weekdays, 8 a.m. to 5 p.m. ET) or by email at pv@risingpharma.com To arrange a return. If you take tablets from an affected group and feel any unusual symptoms — especially swelling, difficulty breathing, dizziness, or hives — contact your doctor. Adverse reactions may also be reported directly to the FDA’s MedWatch program online.
Source: US Food and Drug Administration, “Unique Pharmaceutical Laboratories… Issues Voluntary Nationwide Recall of Cetirizine Hydrochloride 5 mg Tablets Under the US Pharmacopeia Due to Potential Ranitidine Cross-Contamination” (July 20, 2026).
