SerpApi.Org
Take allergy medicine? Check your medicine cabinets. Four lots of the widely used allergy medication are being recalled because they may also contain ranitidine-an entirely different drug with a complicated safety history.
The affected five-milligram tablets were manufactured in India by Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals, commonly known as JB Pharma, and distributed in the U.S. by Rising Pharma Holdings. Cetirizine is the generic form of Zyrtec, an antihistamine commonly used to relieve sneezing, a runny nose, itchy or watery eyes and hives.
JB Pharma also markets ranitidine in India under the brand name Rantac. However, the recall notice does not identify the source of the ranitidine, explain how it entered the cetirizine or indicate whether the two medications were manufactured or packaged in the same facility. Rising Pharma and JB Pharma have not publicly provided additional details about the apparent cross-contamination.
Those questions are particularly pressing because the problem was apparently not caught inside the manufacturing facility.
A Pharmacy Technician Spotted the Red Flags
According to the recall notice, a U.S. pharmacy technician noticed red dots and discoloration while counting the cetirizine tablets before dispensing them. The company has not explained why the visibly irregular pills were not caught during manufacturing, quality-control testing or packaging.
The discovery prompted the recall. It also raises questions about why the visible irregularities were not identified during manufacturing, quality-control testing or packaging.
Why Ranitidine Raises Concern
The FDA requested the withdrawal of all ranitidine products from the U.S. market in 2020 after finding that levels of N-nitrosodimethylamine, or NDMA, could increase over time and with heat exposure. NDMA is classified as a probable human carcinogen.
India did not institute the same market-wide withdrawal. JB Pharma continued marketing Rantac there, and the company's current website continues to list ranitidine-containing formulations.
The FDA approved a reformulated ranitidine for the U.S. in November 2025. However, the recall notice does not say which formulation contaminated the cetirizine or whether the tablets were tested for NDMA. There is currently no evidence that the recalled allergy medication contains NDMA or creates a cancer risk. The stated danger is exposure to an undeclared drug and the risk of severe reactions among people with ranitidine hypersensitivity.
The recall may be particularly relevant to women in midlife, when fluctuating estrogen levels can influence histamine activity and potentially intensify allergy symptoms. Allergy medication is also part of many women's daily routines: 2025 YouGov Profiles data found that 21% of women take it at least once a day, compared with 15% of men.
When a medication is used that routinely, an undeclared drug entering the bottle is more than a technical manufacturing error. It undermines the basic trust consumers place in the label - and in the safeguards meant to ensure that the pill they take is the pill they intended to purchase.
What to Do Next: Check Your Medicine Cabinet
Check bottles of Cetirizine Hydrochloride Tablets USP 5 mg containing 100 tablets. The recalled products have NDC 16571-401-10, an expiration date of 10/2028 and one of the following lot numbers:
- GY825029
- GY825030
- GY825031
- GY825032
Consumers can contact Rising Pharma at 1-844-874-7464 from 8 a.m. to 5 p.m. Eastern time, Monday through Friday, or at [email protected] or [email protected]. Contact a health care provider if you experienced a problem that may be related to the medication. Adverse events and product-quality concerns may also be reported through the FDA's MedWatch program.
