Mibelas 24 Fe Recall Issued Due to Risk Birth Control Pills Out of Sequence

Lupin Pharmaceuticals warns that some packages of Mibelas 24 Fe birth control pills distributed throughout the U.S. may be out of sequence, causing a risk that women may not receive intended protection against unwanted pregnancy.

The Mibelas 24 Fe recall was announced May 25, impacting a specific lot of the birth control (norethindrone acetate and ethinylestradiol 1mg/0.02 mg chewable tablets and ferrous fumarate 75 mg) with a May 2018 expiration date.

The Baltimore-based pharmaceutical company initiated the birth control recall after packets were found to include out of sequence tablets, or packets missing expiration dates and lot information.

Lupin indicates that it has received multiple complaints concerning the packing error, including reports that the blister packs were rotated 180 degrees within the pill packet, reversing the tablet order and weekly orientation. The rotation also causes the lot number and expiration date to no longer be visible by the user.

With this problem, the first four pills would include non-hormonal placebo pills instead of active ingredient pills.

Taking oral contraceptives out of proper order exposes women to a serious risk of birth control pill failure and unintended pregnancy. The reversed order, or taking the pills out of proper sequence, may not be apparent to a new or even long-time user of the product or brand.

“For patients in whom a pregnancy is contraindicated or in whom concomitant medication(s) may have teratogenic effects, an unintended pregnancy may cause significant adverse maternal or fetal health consequences, including death,” the FDA recall notice warns.

Mibelas 24 Fe is packaged in a 28 tablet blister pack with 24 white to off-white pills, which include active ingredients. These pills are stamped with “LU” on one side and “N81” on the other. The pack also includes four tablets of non-active or placebo ingredients. These pills are stamped with “LU” on one side and “M22” on the other.

So far, there have been no reports of adverse events. However, similar birth control packaging errors have led to unintended pregnancy in the past.

Unintended pregnancy could cause devastating consequences for women, including teens who may be taking the birth control pills. Serious medical consequences could also result for some women if they get pregnant, as well as increased risks of birth controls or malformations for women who have been told not to get pregnant for medical reasons.