After high levels of potential carcinogens forced Pfizer to pull multiple products in Canada, the company's recall saga has reached the U.S.
Pfizer is recalling five lots of Accupril tablets, also known as quinapril HCL, after testing flagged levels of a nitrosamine—N nitroso-quinapril—above acceptable daily limits.
Nitrosamines are ubiquitous, popping up in water and foods like cured and grilled meats, plus dairy products and vegetables. Everyone is exposed to nitrosamines in some capacity, and the risk of cancer only follows high-level exposure over a long stretch of time.
Accupril is approved for hypertension to lower blood pressure. It’s also cleared to manage heart failure as an add-on therapy to meds like diuretics or digitalis, Pfizer said.
As of Friday, Pfizer said it hadn’t received any safety reports linked to the recalled drugs. The company touted Accupril’s more than 30-year safety track record, adding it believes the benefits of the med outweigh the risks based on current data.
“Although long-term ingestion of Nnitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication,” Pfizer said in a release posted on the FDA’s website. “Patients currently taking the products should consult with their doctor or health care provider about alternative treatment options for them.”
Pfizer distributed the five Accupril lots nationwide across the U.S. and Puerto Rico between December 2019 and April 2022.
The lots, which contained 90-count bottles of 10-, 20- and 40-mg Accupril, were set to expire at the end of next March and May.
Nitrosamines have been the culprit behind countless recalls in recent years—most notably on valsartan blood pressure meds and metformin diabetes drugs. An overabundance of nitrosamines also prompted Pfizer’s sweeping Chantix recall in 2021.
In Canada, meanwhile, Pfizer recently pulled two separate blood pressure med batches—also on nitrosamine fears. Those meds were Accuretic, of which Pfizer recalled all lots in the Great White North, and Inderal, of which Pfizer yanked 15 batches.