The Miami Herald reports Pfizer announced a recall of 12 more lots of varenicline, otherwise known as Chantix, following a similar recall announced on July 2. According to the Herald, “both recalls, the latest on Friday, concern the presence of N-nitroso-varenicline” at levels that exceed Pfizer’s acceptable daily intake level, but not the FDA’s limit. The recall notice said, “Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication.” The notice also added that “the health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.”

Medscape  reports the FDA announced on July 16 that “it would not object to distribution of varenicline that contained levels of the nitrosamine impurity higher than its acceptable intake limit of 37 ng/d, but lower than the interim acceptable intake limit of 185 ng/d, until the impurity can be eliminated or reduced to acceptable levels,” in the interest of ensuring access to the smoking cessation drug.

From the news release of the American Association for Justice.