Alysena 28 Birth Control Recall Issued Due to Risk of Unwanted Pregnancy

A packaging error may have left many Canadian women taking Alysena-28 birth control pills unprotected from pregnancy. 

An Alysena 28 birth control pill recall has been issued after it was determined that some packages may contain two weeks’ worth of placebo tablets and two weeks of birth control pills by mistake.

Apotex, the distributor issued a recall on April 9, but some women have complained that the company only informed distributors, and failed to inform consumers using the pills about the birth control recall.

Initially, Apotex classified its actions as a voluntary Type II recall. However, Health Canada, the Canadian drug and health enforcement agency, upgraded the recall to Type I because some women take the pills because they cannot get pregnant due to medical reasons.

The Alysena 28 blister packs are supposed to contain 21 active ingredient pills and seven placebo pills. However, the recalled packets may contain 14 of each, reducing the effectiveness of the pills’ birth control effects. The recalled blister packs have a lot number of LF01899A and were distributed across Canada.

There were similar recalls for birth control pill manufacturing errors issued in the United States last year. In June, ten lots of Introvale birth control pills were recalled after a consumer discovered the placebo pills had been placed in the wrong row.

In February 2012, Glenmark Generics issued a norgestimate and ethinyl estradiol birth control recall, also due to packaging issues. A month before that, Pfizer recalled about one million packs of Lo/orval-28 and generic norgestrel birth control pills due to similar problems, where some blister packs in 28 different lots were identified as potentially containing the wrong number of pills and out of sequence tablets.

Apotex is recommending that women who believe they received and used one of the improperly packaged Alysena 28 blister packs use a non-hormonal method of contraception until they talk to their physician.