Pfizer has voluntarily recalled 14 lots of Lo/Ovral-28 (norgestrel and ethinyl estradiol) tablets and 14 lots of Norgestrel and Ethinyl Estradiol tablets (generic) on the U.S. market—approximately 1 million packs.
“Recently, it came to our attention that there may be an issue with the way some of these pills were packaged…and that the inactive or placebo pill may have been placed out-of-order in some packs,” said a Pfizer statement.
An investigation by Pfizer found that some blister packs may contain an inexact count of inert or active ingredient tablets and that the tablets may be out of sequence. The cause was identified and corrected immediately.
“Based on our own rigorous internal assessments of this problem, we believe there are approximately 30 packs of birth control pills that may have received an inexact count or inactive tablet,” said the Pfizer statement. “Because of our high-quality standards, should we identify even one package that does not meet our high standards, we will voluntarily recall the entire lot.”
As a result of the packaging error, the daily regimen for the oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy. These packaging defects do not pose any immediate health risks. However, Pfizer advised consumers exposed to the affected packaging to begin using a non-hormonal form of contraception immediately.
For a full list of recalled lot numbers, visit the Pfizer web site.