An Allergy Pill Recall Traces Back to Ranitidine, a Drug Pulled From Shelves Years Ago
34,200 bottles of cetirizine tablets show red dots the manufacturer traced to ranitidine residue. The FDA has classified it at its highest risk level.
Meridians Life Desk
Published 21 August 2026 · Updated 21 August 2026 · 4 min read
HealthThe short answer
- Rising Pharma Holdings recalled four lots — 34,200 bottles — of cetirizine hydrochloride 5 mg tablets after red-colored dots were traced to ranitidine cross-contamination.
- The FDA classified the recall Class I, its highest risk category, reserved for situations where a product could cause serious health consequences or death.
- People sensitive to ranitidine could face severe hypersensitivity reactions or anaphylaxis, including breathing difficulty and throat swelling, though no adverse events have been reported so far.
- The affected lots — GY825029, GY825030, GY825031 and GY825032 — expire in October 2028 and were distributed nationwide.
Rising Pharma Holdings has recalled four lots of cetirizine hydrochloride tablets — a common over-the-counter allergy antihistamine — after tablets turned up with red dots that testing traced to cross-contamination with ranitidine, a heartburn medication once sold as Zantac and removed from the market industry-wide after contamination concerns. The FDA has classified the recall Class I, its most serious risk category.
What triggered the recall
Rising Pharma says testing confirmed the red dots were ranitidine residue introduced during manufacturing or packaging. Cetirizine and ranitidine are unrelated drugs — one an antihistamine, the other a heartburn medication — and the company has not detailed exactly how the cross-contamination occurred.
Which bottles are affected
- Cetirizine Hydrochloride Tablets USP, 5 mg, 100-count bottles
- Lot numbers GY825029, GY825030, GY825031 and GY825032, all expiring October 2028
- 34,200 bottles distributed nationwide by Rising Pharma Holdings, manufactured by Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd.
The health risk
People with a sensitivity to ranitidine could have a severe hypersensitivity reaction, including difficulty breathing, throat swelling, hives or loss of consciousness, according to the recall notice. No adverse events had been reported to the FDA as of the recall announcement.
What to do
- Check your bottle against the four lot numbers above
- Stop taking the tablets immediately if your lot matches
- Contact your physician if you've had any reaction after taking them
- Report problems to FDA MedWatch at 1-800-332-1088 or fda.gov/medwatch
- Call Rising Pharma at 1-844-874-7464 (Monday-Friday, 8 a.m.-5 p.m. ET) with product questions
Sources
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Meridians Life Desk is an editorial desk at Meridians, not an individual. A desk byline means the article was produced and fact-checked to that desk's published standards. Read our editorial standards and corrections policy.
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