Recall: Birth control pills Lo/Ovral-28 and Norgestrel/Ethinyl Estradiol—Incomplete and incorrect tablet count

Consumer Reports News: February 01, 2012 10:53 AM

Pfizer has recalled 14 lots of its birth control pills Lo/Ovral-28, and 14 lots of the generic version Norgestrel and Ethinyl Estradiol, because of a packaging error that could cause the daily regimen for these oral contraceptives to be incorrect, leaving women at risk for unintended pregnancy.

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.

These birth control pills are distributed to clinics, retail pharmacies and warehouses nationwide, and are manufactured and packaged by Pfizer, commercialized by Akrimax Rx Products, and labeled under the Akrimax Pharmaceuticals brand.

Consumers taking the recalled birth control pills should begin using a non-hormonal form of contraception immediately, and notify their physician and return the product to the pharmacy. For a full list of the lot numbers affected by this recall click here.

These products are packaged in blister packs of 21 tablets of active ingredients and seven tablets of inert ingredients. Correct dosing is important in avoiding the associated risks of an unplanned pregnancy. Adverse events that may be related to the use of these pills should be reported to Akrimax Medical Information at 877-509-3935, or to the FDA's Med Watch Program.