Allergy Drug Recall Due to Potentially Dangerous Mix-up
WHO:
Fox Business - Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd., based in Panoli, Gujarat, India, is involved in the recall.
USA Today - Rising Pharma Holdings Inc., based in New Jersey, is the distributor of the recalled medication.
WHAT:
Fox Business - The FDA warned that symptoms of anaphylaxis may include low blood pressure, difficulty breathing, trouble swallowing, swelling of the throat or face, intense itching, hives, and loss of consciousness.
USA Today - The recall was initiated by Unique Pharmaceutical Laboratories on July 18.
Fast Company - The potential cross-contamination was identified when a pharmacy technician noticed discrepancies while counting tablets, including a "red dot" on some tablets and discoloration on others.
Fox Business - Unique Pharmaceuticals has not received any reports of adverse events associated with the recall.
USA Today - Rising Pharma Holdings Inc. stated that customers who have a sensitivity to ranitidine and take the contaminated cetirizine hydrochloride tablets may suffer anaphylaxis.
Fast Company - The FDA warned that individuals who are hypersensitive to the ingredients in ranitidine can experience “serious adverse events” if the medication is ingested.
Fox Business - The FDA stated that ranitidine was removed from the U.S. market in 2020 due to concerns over contamination with a probable human carcinogen.
Fox Business - A reformulated version of ranitidine was approved by regulators in 2025.
USA Today - The recalled product is identified by the National Drug Code No. 16571-401-10.
Fox Business - The FDA stated that the recalled cetirizine hydrochloride tablets are commonly sold over the counter as generic versions of Zyrtec.
Fast Company - The FDA warned that individuals who are hypersensitive to ranitidine could experience "severe hypersensitivity reactions and anaphylaxis" if they ingest the contaminated tablets.
Fox Business - The U.S. Food and Drug Administration (FDA) announced a recall of certain lots of Cetirizine hydrochloride Tablets due to potential cross-contamination with ranitidine.
USA Today - Four lots of 5-milligram cetirizine hydrochloride tablets are being recalled.
Fox Business - The affected lots include GY825029, GY825030, GY825031, and GY825032, all with an expiration date of October 2028.
USA Today - The recalled product is packaged in high-density polyethylene (HDPE) bottles containing 100 tablets.
WHERE:
Fox Business - The recalled products were distributed nationwide to wholesalers and retailers.
WHEN:
USA Today - The recall was initiated on July 18.
Fox Business - The FDA announced the recall on a Monday following the initiation.
WHY:
Fast Company - The potential cross-contamination was identified when a pharmacy technician noticed discrepancies while counting tablets, including a "red dot" on some tablets.
Fox Business - The recall was initiated due to concerns that the cetirizine tablets may have been contaminated with ranitidine, which could cause "life-threatening" reactions in sensitive individuals.
USA Today - The issue was discovered when a pharmacy technician noticed discrepancies while counting tablets, including a "red dot" on some tablets.
HOW:
ABC News - Unique Pharmaceuticals notified its distributor, Rising Pharma Holdings Inc., about the recall, which then informed distributors and customers via email.
USA Today - Customers can report adverse reactions or quality problems to the FDA's MedWatch Adverse Event Reporting program by completing and submitting a report at www.fda.gov.
USA Today - Customers can also download the reporting form for adverse reactions from www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form.
USA Today - Rising Pharma Holdings Inc. stated that customers can report adverse reactions or quality problems to the FDA's MedWatch Adverse Event Reporting program by completing and submitting a report at www.fda.gov.
Fox Business - Consumers with questions about the recall can contact Rising Pharma Holdings Inc. at 1-844-874-7464 or email pv@risingpharma.com.
USA Today - Customers can report adverse reactions or quality problems to the FDA's MedWatch Adverse Event Reporting program by completing and submitting a report at www.fda.gov.
(UPDATED July 23, 2026 01:27 UTC)
The FDA has issued a warning regarding symptoms of anaphylaxis, which can include low blood pressure, difficulty breathing, and swelling of the throat or face. This alert follows a recall initiated by Unique Pharmaceutical Laboratories on July 18, after a pharmacy technician discovered potential cross-contamination while counting tablets. Unique Pharmaceuticals promptly notified its distributor, Rising Pharma Holdings Inc., which then communicated the recall to distributors and customers through email.
--
(UPDATED July 22, 2026 20:23 UTC)
Unique Pharmaceuticals has not reported any adverse events related to their recent recall, while Rising Pharma Holdings Inc. has cautioned that customers sensitive to ranitidine could face anaphylaxis from contaminated cetirizine hydrochloride tablets. The FDA has issued a warning that individuals hypersensitive to ranitidine's ingredients may experience serious adverse events if they ingest the medication. Customers are encouraged to report any adverse reactions or quality issues to the FDA's MedWatch Adverse Event Reporting program by visiting www.fda.gov.
--
(UPDATED July 22, 2026 16:24 UTC)
The FDA announced that ranitidine was removed from the U.S. market in 2020 due to contamination concerns linked to a probable human carcinogen, but a reformulated version received regulatory approval in 2025. The recalled product can be identified by the National Drug Code No. 16571-401-10. Customers who experience adverse reactions can download a reporting form from the FDA's website or call 1-800-332-1088 to request one.
--
(UPDATED July 22, 2026 15:31 UTC)
The FDA has issued a recall for cetirizine hydrochloride tablets, which are often sold over the counter as generic versions of Zyrtec, due to potential contamination. The agency warns that individuals hypersensitive to ranitidine could face severe reactions, including anaphylaxis, if they consume these affected tablets, a concern raised after a pharmacy technician noticed discrepancies during inventory checks. Customers who experience adverse reactions or quality issues are encouraged to report them to the FDA's MedWatch Adverse Event Reporting program by visiting www.fda.gov.
--
(UPDATED July 22, 2026 07:50 UTC)
The U.S. Food and Drug Administration has announced a recall of certain lots of Cetirizine hydrochloride Tablets due to potential cross-contamination with ranitidine, which could lead to serious health risks for sensitive individuals. Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd. in India, is recalling four lots of the medication, identified as GY825029, GY825030, GY825031, and GY825032, all set to expire in October 2028, and these products were distributed nationwide. Consumers with questions can reach out to Rising Pharma Holdings Inc. at 1-844-874-7464, and anyone experiencing adverse reactions is encouraged to report them through the FDA's MedWatch program.