Cetirizine Recall: Check These 4 Affected Lots

Rising Pharma Holdings Inc. recalled four lots of generic cetirizine allergy tablets across the United States because they may contain traces of ranitidine. The cetirizine recall applies only to selected bottles distributed by Rising Pharma Holdings Inc., not every cetirizine or Zyrtec product.

Consumers should check the NDC, lot number, and expiration date printed on their medicine bottle. The recalled product is Cetirizine Hydrochloride Tablets USP, 5 mg, packaged in 100-tablet bottles.

Quick Answer

Unique Pharmaceutical Laboratories voluntarily recalled four lots of Cetirizine Hydrochloride Tablets USP, 5 mg, at the consumer level. All affected bottles have NDC 16571-401-10, contain 100 tablets, and expire in October 2028.

The affected lot numbers are:

• GY825029
• GY825030
• GY825031
• GY825032

The company announced the recall after a pharmacy technician found red dots or discoloration on some tablets during dispensing. At that time, the company had received no reports of related adverse events.

Cetirizine Recall Quick Facts

The company announced the recall on July 18, 2026, and the U.S. Food and Drug Administration published the announcement on July 20. The FDA posts company recall announcements as a public service and does not endorse the company or product.

Which Cetirizine Products Were Recalled?

The recall applies to four lots of Cetirizine Hydrochloride Tablets USP, 5 mg, manufactured by Unique Pharmaceutical Laboratories and distributed by Rising Pharma Holdings Inc.

The company packaged the medicine in high-density polyethylene bottles containing 100 tablets and distributed it nationwide through wholesalers and retailers.

Consumers should not rely only on the medicine’s generic name. Check the distributor, strength, bottle size, NDC, lot number, and expiration date to confirm whether the recall covers your bottle.

What Are the Cetirizine Recall Lot Numbers?

The following four lots are included in the recall:

The lot number and expiration date should appear on the bottle label. Consumers who received tablets in a pharmacy container and cannot find the original manufacturer information should contact the pharmacy that dispensed the medicine.

The complete product information and bottle photographs are available in the official FDA cetirizine recall announcement.

Why Were the Cetirizine Tablets Recalled?

The company recalled the tablets because they may contain traces of ranitidine.

According to the FDA-posted company announcement, a pharmacy technician noticed a discrepancy while counting tablets during dispensing. A product complaint described red dots on some tablets and discoloration caused by multiple red-colored dots.

The recall notice does not say that contamination affects every tablet or bottle in the four lots. The company issued the recall to remove those lots from consumers and the distribution system while it investigates and resolves the issue.

What Health Risk Was Identified?

The company’s risk statement focuses on consumers who are hypersensitive to ingredients in ranitidine.

According to the recall notice, consuming a contaminated tablet could potentially cause a serious hypersensitivity reaction in a susceptible person. Possible signs described in the announcement include:

• Difficulty breathing
• Difficulty swallowing
• Swelling of the face or throat
• Hives or severe itching
• Low blood pressure
• Loss of consciousness

These are potential risks described in the recall announcement, not confirmed effects in everyone who used the product. Unique Pharmaceutical Laboratories reported that it had received no adverse-event reports connected to the recall as of its July 18 announcement.

Anyone experiencing difficulty breathing, facial or throat swelling, loss of consciousness or another severe allergic reaction should seek urgent medical assistance.

Is All Cetirizine or Zyrtec Recalled?

No. The recall does not apply to every cetirizine or Zyrtec product.

The notice is limited to four lots of a specific generic product:

• Cetirizine Hydrochloride Tablets USP
• 5 mg strength
• 100-tablet bottle
• NDC 16571-401-10
• Distributed by Rising Pharma Holdings Inc.
• Expiration date October 2028

The FDA announcement does not identify every generic cetirizine product or branded Zyrtec as affected. Consumers should compare the identifiers on their bottles with the official recall information rather than discarding medicine based only on its active ingredient.

Do not confuse this recall with the FDA’s separate 2025 safety communication, which warned about rare, severe itching after some patients stopped long-term cetirizine or levocetirizine use. That warning concerns a different issue and is not the reason for this four-lot recall.

What Should Consumers Do With an Affected Bottle?

Consumers who may have an affected product can take the following steps:

1. Check the product name, strength and bottle size.
2. Confirm whether the NDC is 16571-401-10.
3. Compare the lot number with the four recalled lots.
4. Check whether the expiration date is October 2028.
5. Set aside any matching bottle to prevent anyone from accidentally using it or giving it to someone else.
6. Contact the dispensing pharmacy or Rising Pharma for return and replacement instructions.
7. Speak with a pharmacist or healthcare professional before changing an ongoing allergy-treatment plan.
8. Contact a healthcare provider if you think the medicine may have caused a health problem.

The FDA advises consumers checking a drug recall to compare the lot number on their label with the number in the recall notice. A pharmacy or healthcare provider may also notify patients when a dispensed medicine is recalled. More information is available in the FDA’s guide to understanding drug recalls.

How Can Consumers Contact Rising Pharma?

Consumers with general or medical questions about the recall can contact Rising Pharma Holdings Inc.

• Telephone: 1-844-874-7464
• Hours: Monday through Friday, 8 a.m. to 5 p.m. Eastern time, as listed in the recall notice
• Medical or safety email: pv@risingpharma.com
• Quality email: qa@risingpharma.com

The manufacturer notified Rising Pharma, which then contacted distributors and direct customers and arranged the return of the recalled products.

How Can You Report a Reaction to the FDA?

Consumers and healthcare professionals can report adverse reactions or product-quality concerns through the FDA MedWatch program.

Reports may be submitted online. The recall announcement also lists options for requesting and submitting a MedWatch form by mail or fax. Reporting a suspected problem does not prove that the medicine caused it, but reports can help regulators monitor potential safety issues.

Readers can also review the FDA’s regularly updated recalls, market withdrawals and safety alerts database to check whether this recall has been expanded, classified or terminated. As of July 23, 2026, the FDA listing did not show the cetirizine recall as terminated.

What Remains Unknown?

The initial announcement does not establish:

• Whether every bottle from an affected lot contains a discolored or contaminated tablet
• How many bottles reached individual consumers
• Whether the FDA will assign a formal recall classification
• Whether additional lots will be added
• Whether new adverse-event reports will emerge

Do not present these points as confirmed until the FDA or the company publishes updated information.

For continuing coverage of recalls and safety notices, visit Fresh Global News Health and the site’s Public Health coverage.

Frequently Asked Questions

Q1. Which cetirizine lot numbers does the recall cover?

The recalled lot numbers are GY825029, GY825030, GY825031 and GY825032. All four belong to Cetirizine Hydrochloride Tablets USP, 5 mg, in 100-tablet bottles with NDC 16571-401-10 and an October 2028 expiration date.

Q2. Is all cetirizine recalled?

No. The recall covers only four lots of one generic cetirizine product from Rising Pharma Holdings Inc. Consumers should check the NDC, lot number, strength, bottle size, and expiration date to confirm whether the recall includes their medicine.

Q3. Does the recall include Zyrtec?

The FDA announcement does not identify branded Zyrtec as a recalled product. It names Cetirizine Hydrochloride Tablets USP, 5 mg, distributed by Rising Pharma. Consumers should confirm the exact product information on their bottle or contact their pharmacy.

Q4. Why did the company recall cetirizine?

The company voluntarily recalled the four lots because they may contain traces of ranitidine. A pharmacy technician first reported the issue after noticing red dots or discoloration on some tablets while dispensing them.

Q5. Were any injuries or adverse reactions reported?

Unique Pharmaceutical Laboratories stated that it had received no reports of adverse events related to the recall as of the July 18, 2026, company announcement. Later updates should be checked through the FDA recall database.

Q6. What should I do if the recall covers my bottle?

Set the matching bottle aside and contact the pharmacy that dispensed it or Rising Pharma for return or replacement instructions. Speak with a pharmacist or healthcare professional before you change ongoing treatment, especially if you use the medicine regularly.

Conclusion

The July 2026 recall covers only four lots of Cetirizine Hydrochloride Tablets USP, 5 mg, distributed by Rising Pharma. It does not include every cetirizine or Zyrtec product.

Consumers should check for NDC 16571-401-10, lot numbers GY825029, GY825030, GY825031 or GY825032, and an October 2028 expiration date. Anyone with a matching bottle should contact the dispensing pharmacy or Rising Pharma for current return and replacement guidance.

Because recall information can change, consumers should continue checking the official FDA announcement and recall database for updates.