Pfizer Recalls Lo/Ovral-28 and Norgestrel / Ethinyl Estradiol Birth Control Medications

norgestrel ethinyl estradiolPfizer Inc. has recalled 14 lots of Lo/Ovral®-28 (norgestrel and ethinyl estradiol) and 14 lots of Norgestrel and Ethinyl Estradiol (generic) birth control pills in the United States (see lot numbers below). Pfizer found that some blister packs may contain an inexact count of inert or active ingredient pills and that the pills may be out of sequence. The cause was identified and corrected immediately, but women who use the recalled birth control may be at a greater risk for unintended pregnancy.

Lo/Ovral-28, Norgestrel Estradiol and Ethinyl Estradiol are oral contraceptives used by women to prevent pregnancy. They are manufactured and packaged by Pfizer Inc., commercialized by Akrimax Rx Products and labeled under the Akrimax Pharmaceuticals brand. The recalled pills were distributed to warehouses, clinics and retail pharmacies across the country.

The daily regimen for these oral contraceptives may be incorrect, and could leave women without adequate contraception. The packaging defects do not pose any immediate health risks. However, Pfizer is asking women who have been taking a recalled batch of birth control pills to begin using a non-hormonal form of contraception immediately. Consumers who have the affected product should notify their doctor and return the pills to their pharmacy.

These medications were packaged in blister packs containing 21 tablets of active ingredients and seven tablets of inert ingredients. Correct dosing of this product is an important part of avoiding an unplanned pregnancy.

Recalled Lot numbers for Packs of Lo/Ovral®-28 (norgestrel and ethinyl estradiol), and Norgestrel and Ethinyl Estradiol (generic) Birth Control Tablets:

NDC Product Lot Expiration Configuration/Count
24090-801-84 LO/OVRAL® 28 E15678 08/31/2013 6 Pilpacks® of 28 tablets each
24090-801-84 LO/OVRAL® 28 E15679 08/31/2013 6 Pilpacks® of 28 tablets each
24090-801-84 LO/OVRAL® 28 E15686 08/31/2013 6 Pilpacks® of 28 tablets each
24090-801-84 LO/OVRAL® 28 E15687 01/31/2014 6 Pilpacks® of 28 tablets each
24090-801-84 LO/OVRAL® 28 E15690 01/31/2014 6 Pilpacks® of 28 tablets each
24090-801-84 LO/OVRAL® 28 E15698 01/31/2014 6 Pilpacks® of 28 tablets each
24090-801-84 LO/OVRAL® 28 E15700 02/28/2014 6 Pilpacks® of 28 tablets each
24090-801-84 LO/OVRAL® 28 E80434 07/31/2013 6 Pilpacks® of 28 tablets each
24090-801-84 LO/OVRAL® 28 E80438 08/31/2013 6 Pilpacks® of 28 tablets each
24090-801-84 LO/OVRAL® 28 F36908 02/28/2014 6 Pilpacks® of 28 tablets each
24090-801-84 LO/OVRAL® 28 F36909 02/28/2014 6 Pilpacks® of 28 tablets each
24090-801-84 LO/OVRAL® 28 F43915 03/31/2014 6 Pilpacks® of 28 tablets each
24090-801-84 LO/OVRAL® 28 F43926 03/31/2014 6 Pilpacks® of 28 tablets each
24090-801-84 LO/OVRAL® 28 F43927 03/31/2014 6 Pilpacks® of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg E15677 08/31/2013 6 Pilpacks® of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg E15704 01/31/2014 6 Pilpacks® of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg E15706 01/31/2014 6 Pilpacks® of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg E80440 08/31/2013 6 Pilpacks® of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg F16388 01/31/2014 6 Pilpacks® of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg F16390 02/28/2014 6 Pilpacks® of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg F22132 02/28/2014 6 Pilpacks® of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg F31330 02/28/2014 6 Pilpacks® of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg F36911 03/31/2014 6 Pilpacks® of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg F36913 03/31/2014 6 Pilpacks® of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg F43924 03/31/2014 6 Pilpacks® of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg F43925 03/31/2014 6 Pilpacks® of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg F43934 03/31/2014 6 Pilpacks® of 28 tablets each
24090-961-84 Norgestrel 0.3 mg/Ethinyl Estradiol 0.03 mg F53238 03/31/2014 6 Pilpacks® of 28 tablets each

Also see: Yasmin Birth Control Warning: Risk of Heart Attack and Stroke

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Many of our food, drug and medical device recall alerts come from press releases distributed by the United States Food and Drug Administration (FDA) for public use and redistribution by news outlets likes US Recall News.

There are 3 comments. Add yours.

  1. Tram

    Randi, it might be worth your while to check to see what your health dtpnremeat is doing in the meantime. They may have replaced their recalled stock with other lots of the same brand or possibly something else. Or it’s possible that they didn’t have any of the recalled lots at. If you are not ready for another baby, at least trying might help prevent facing an unwanted situation. Good luck!

    Reply
  2. Brittany Landers

    I have a pack of those pills on the recall list and have taken most of them and i will be getting a lawyer!

    Reply
  3. Meghan Flavell

    I was wondering if Tilia Fe 28 pack is part of the recall?

    Reply

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