Unique Pharmaceutical Laboratories, a division of J B Chemicals & Pharmaceuticals Ltd, has initiated a voluntary nationwide recall of four lots of Cetirizine Hydrochloride Tablets USP 5 mg, the generic equivalent of the brand-name drug Zyrtec. The recall was initiated because of possible cross-contamination with ranitidine — the generic equivalent of the brand-name drug Zantac — after discolored tablets were discovered in the affected product.
The issue came to light after a pharmacy technician noticed an unusual appearance while counting tablets for dispensing. According to the recall announcement, the technician reported an “Appearance of red dot on Tablets of Cetirizine Hydrochloride Tablets USP 5 mg and some tablets are discolored (Appeared as discolored due to multiple red colored dots on tablets).” The complaint prompted an investigation that ultimately led to the nationwide recall.
Although no adverse events have been reported, the company warned that consumers who are hypersensitive to ingredients in ranitidine could experience severe allergic reactions if they ingest contaminated tablets. Potential symptoms include difficulty breathing, difficulty swallowing, swelling of the throat or face, hives, widespread itching, dangerously low blood pressure, loss of consciousness, and life-threatening anaphylaxis.
While ranitidine was widely used for many years to treat heartburn and stomach ulcers, it was withdrawn from the US market in 2020 because of concerns about unacceptable levels of the probable carcinogen NDMA. This recall, however, is unrelated to those concerns. Instead, the immediate risk involves accidental exposure for people who are hypersensitive to ingredients in ranitidine, who could experience a severe allergic reaction if contaminated tablets are consumed.
The recalled antihistamine was distributed nationwide to wholesalers and retailers. While no illnesses or injuries have been reported, the contaminated tablets could pose a serious health risk to consumers who are allergic or hypersensitive to ingredients in ranitidine.
The recall specifically covers 100-count High-Density Polyethylene (HDPE) bottles of Cetirizine Hydrochloride Tablets USP 5 mg bearing National Drug Code (NDC) 16571-401-10. The four affected lots—GY825029, GY825030, GY825031, and GY825032—all carry an expiration date of October 2028 (10/2028):
| NDC | Manufacturer | Distributed By | Product Description | Lot Numbers | Expiration Date |
|---|---|---|---|---|---|
| 16571-401-10 | Unique Pharmaceutical Laboratories | Rising Pharma Holdings Inc. | Cetirizine Hydrochloride Tablets USP 5 mg, Pack 100’s HDPE container | GY825029 | 10/2028 |
| 16571-401-10 | Unique Pharmaceutical Laboratories | Rising Pharma Holdings Inc. | Cetirizine Hydrochloride Tablets USP 5 mg, Pack 100’s HDPE container | GY825030 | 10/2028 |
| 16571-401-10 | Unique Pharmaceutical Laboratories | Rising Pharma Holdings Inc. | Cetirizine Hydrochloride Tablets USP 5 mg, Pack 100’s HDPE container | GY825031 | 10/2028 |
| 16571-401-10 | Unique Pharmaceutical Laboratories | Rising Pharma Holdings Inc. | Cetirizine Hydrochloride Tablets USP 5 mg, Pack 100’s HDPE container | GY825032 | 10/2028 |
Unique Pharmaceutical Laboratories notified its US distributor, Rising Pharma Holdings Inc. of East Brunswick, New Jersey, to coordinate the recall. Rising Pharma has notified its downstream distributors and direct customers by email and is arranging for the return of all recalled products.
Consumers and healthcare providers with questions about the recall can contact Rising Pharma Holdings Inc. at 1-844-874-7464 Monday through Friday from 8:00 a.m. to 5:00 p.m. EST, or by email at pv@risingpharma.com or qa@risingpharma.com. Anyone who experiences an adverse reaction or other problem that may be related to taking the recalled medication should contact their healthcare provider and report the event to the FDA’s MedWatch Adverse Event Reporting Program online, by mail, or by fax.
