Millions of people rely on over-the-counter allergy medicine every allergy season, but a newly announced nationwide recall is raising fresh concerns about medication safety. U.S. health regulators are warning consumers to check their medicine cabinets after certain generic cetirizine tablets—commonly sold as the generic version of Zyrtec—were recalled over fears they may have been contaminated with a different medication.
According to FOX Business, the U.S. Food and Drug Administration (FDA) announced the recall after identifying a potential cross-contamination issue involving cetirizine hydrochloride tablets and ranitidine, a drug previously removed from the U.S. market over safety concerns. While no injuries have been reported so far, officials say the contamination could trigger severe allergic reactions in some consumers.
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FDA warns recalled generic Zyrtec tablets could trigger severe allergic reactions
The voluntary recall was initiated on Saturday by Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd., based in Panoli, Gujarat, India. The FDA publicly announced the recall on Monday.
The affected product is Cetirizine Hydrochloride Tablets USP 5 mg, packaged in a high-density polyethylene (HDPE) bottle containing 100 tablets under National Drug Code (NDC) 16571-401-10.
Regulators say the tablets may have been cross-contaminated with ranitidine, a medication once widely sold under the brand name Zantac to reduce stomach acid. Ranitidine was removed from the U.S. market in 2020 after concerns that it could contain a probable human carcinogen. A reformulated version of the medication was later approved by U.S. regulators in 2025.
The FDA warned that people who are hypersensitive to ingredients found in ranitidine could face serious adverse events, including anaphylaxis, a rapid and potentially life-threatening allergic reaction.
The agency stated:
“For consumers with a hypersensitivity to the ingredients in ranitidine, there is a reasonable probability that ingestion of cetirizine tablets contaminated with ranitidine could result in serious adverse events.”
Symptoms of anaphylaxis may include:
- Low blood pressure
- Difficulty breathing
- Trouble swallowing
- Swelling of the throat or face
- Severe itching
- Hives
- Loss of consciousness
How the contamination was discovered and which lots are affected
The problem reportedly came to light after a pharmacy technician noticed unusual tablets while counting medication during dispensing.
According to the FDA, some tablets displayed a red dot, while others appeared discolored or contained multiple red-colored spots, prompting further investigation.
The recalled tablets were distributed nationwide to wholesalers and retailers across the United States.
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Official recall details
| Detail | Information |
| Product | Cetirizine Hydrochloride Tablets USP 5 mg |
| Commonly sold as | Generic Zyrtec |
| Package | HDPE bottle containing 100 tablets |
| NDC | 16571-401-10 |
| Recalled lots | GY825029, GY825030, GY825031, GY825032 |
| Expiration date | October 2028 |
| Recall initiated by | Unique Pharmaceutical Laboratories |
| FDA announcement | Monday |
| Distribution | Nationwide |
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Company says no adverse events have been reported
Despite the seriousness of the potential contamination, Unique Pharmaceuticals said it has not received any reports of adverse events linked to the recalled medication.
The company has notified its distributor, Rising Pharma Holdings Inc., which is managing the recall process.
Consumers who have questions about the recalled tablets can contact Rising Pharma Holdings Inc. by phone at 1-844-874-7464 between 8 a.m. and 5 p.m. ET, Monday through Friday, or by email at pv@risingpharma.com.
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Health officials advise anyone who possesses one of the affected lots to verify the lot number on the bottle and seek guidance from the distributor or a healthcare professional if they have concerns, particularly if they experience symptoms consistent with an allergic reaction.
Source: Fox Business
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