Provider Alert: Mibelas birth control pills recalled, packaging error could cause unexpected pregnancy

Lupin Pharmaceuticals has recalled their widely-distributed oral contraceptive Mibelas 24 Fe. The packaging of the recalled pills inadvertently reversed the position of the first and last four pills.  The first four pills of these packs were non-hormonal placebo pills, while the last four of the pack included the active hormonal pills intended for the first four days.

While the placebo pills are a different color, the error could easily go unnoticed by new or unobservant users.  And because the mistake interferes with the pill’s efficacy, users could experience unexpected pregnancies.  The FDA recall announcement also warned that an unexpected pregnancy resulting from the use of the placebo pills first, and then followed by taking more of the hormonal pills in the pack, could have teratogenic effects (damaging to the fetus)

This packaging error has also made it impossible to read the expiration date of the pack.

Lupin has notified pharmacies who distributed the pills of the recall. Women who purchased these pills are asked to return them to the pharmacy where they were purchased and to contact their healthcare provider if they could be pregnant.

Providers who have prescribed Mibelas should also reach out to these patients to notify them of the recall.  They may also wish to encourage backup contraception until the patient’s next menstrual cycle and monitoring for an unexpected pregnancy.

Read More

(1) Samuelson, Kate. Birth Control Pills Recalled Because Packaging Error Could Lead to Unintended Pregnancy, Time Health (Jun 9, 2017).

(2) Greenwood, Max. FDA recall warns of risk for unintended pregnancy, The Hill (Jun 10, 2017).

(3) Carol, Linda. Birth control pills recalled due to packaging error, Today (Jun 9, 2017).

about the author

Erin K. Jackson is Jackson LLP’s Managing Partner. She is responsible for all aspects of firm management, is a sought-after speaker for healthcare conferences, and is a published author. She is specifically focused upon the intersection of the patient experience in healthcare with the legal and ethical responsibilities of providers.

This blog is made for educational purposes and is not intended to be specific legal advice to any particular person. It does not create an attorney-client relationship between our firm and the reader. It should not be used as a substitute for competent legal advice from a licensed attorney in your jurisdiction.