The birth control product includes active and inactive tablets but the packaging error may have led to incorrect numbers of each being included. Pfizer may also have packed the pills in the wrong order and these errors could limit the drug’s effectiveness.
“As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy”, Pfizer wrote in a recall notice shared by the US Food and Drug Administration (FDA).
A spokesperson for Pfizer told Bloomberg it is recalling 1m packets of Lo/Ovral-28 (norgestrel and ethinyl estradiol) and its generic equivalent. Each packet contains 28 oral birth control pills.
Of the 28 pills, 21 should be active and the rest inert. The active tablets, which are white to differentiate them from the inert pink pills, are taken for 21 consecutive days, after which the inactive product is taken for a week.
Failure to follow this dosing regimen raises the risk of unintended pregnancy. Although there are no immediate health risks Pfizer is advising consumers that have taken the affected products to switch to a non-hormonal form of contraception.
Pfizer manufactures and packages the oral contraceptives for Akrimax to commercialise and label. Wyeth Pharmaceuticals first commercialised Lo/Ovral-28, winning FDA approval in 1976, and Pfizer acquired the product as part of its $68bn (€52bn) takeover of the big biopharm business in 2009.