The recall follows out-of-specification results identified during ongoing stability testing at the manufacturing facility. Authorities said there is currently no indication of a high risk to patient safety, but the products are being recalled as a precaution.
Customers have until September 4, 2026, to return the affected Atorstan products to the pharmacy or other location where they were purchased or obtained.
Four lots of Cetirizine Hydrochloride 5 mg tablets have also been recalled because of potential cross-contamination with ranitidine.
The affected lot numbers are GY825029, GY825030, GY825031 and GY825032, all with an expiry date of October 2028.
The antihistamine, manufactured by Unique Pharmaceutical Laboratories and distributed by Rising Pharma Holdings Inc., is used to treat allergic conditions and is packaged in bottles of 100 tablets.
The potential contamination was discovered after a product complaint involving tablets with red dots and discoloration.
Officials warned that people who are hypersensitive to ranitidine could potentially experience serious allergic reactions, including anaphylaxis, if exposed to contaminated tablets. No adverse events associated with the recall have been reported to date.
Consumers who have cetirizine from any of the affected lots have been advised not to use the tablets and to return them to the pharmacy or other place where they were obtained.
Anyone who believes they have experienced a health problem associated with the affected cetirizine should contact their doctor or healthcare provider.
The Department of Pharmaceutical Services is urging the public not to panic but to take the recalls seriously and carefully check the product name, strength and batch or lot number of their medication.
Pharmacies, wholesalers, distributors and healthcare providers have also been asked to immediately review their inventories and remove affected products from circulation.
The Ministry said it will continue monitoring the recalls and provide further information where necessary.