Birth Control Tablets May Have Been Accidentally Switched with Placebo Tablets

A packaging error may have put the tablets out of the correct sequence

Mibelas Birth Control Tablets / Birth Control Tablets May Have Been Accidentally Switched with Placebo Tablets
Image: FDA
June 09, 2017

Lupin Pharmaceuticals has recalled a lot of its Mibelas Tablets birth control tablets because they may have been accidentally switched with placebos, putting users at risk of unintended pregnancy.

The company is recalling lot L600518 and Exp 05/18 of Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) Tablets. The tablets are packaged in blister packs containing 28 tablets in total: 24 tablets with active ingredients that are white to off-white and are debossed with LU on one side and N81 on the other, and four placebo tablets with LU on one side and M22 on the other.

The products were distributed to retail pharmacies, clinics, and wholesalers across the U.S. The affected products include:

  • NDC 68180-911-11: a wallet with 28 tablets, lot number L600518, and expiration date 05/31/2018
  • NDC 68180-911-13: a carton with three wallets, lot number L600518, and expiration date 05/31/2018

A packaging error reversed the orientation of the tablets inside the packaging, making the lot number and expiration date invisible. As a result, the user would have ingested four non-hormonal placebo tablets rather than active birth control tablets for the first four days of birth control therapy.

Oral birth control tablets ingested out of the correct sequence can put the user at risk of contraceptive failure and, therefore, unintended pregnancy. The reversed order may not be apparent either to new users or those who have taken the tablets before, a fact that makes it more likely that the tablets would be ingested out of order.

The company is informing its distributors and customers of the error and recall by letter and is arranging for the return of the affected products. Anyone who has the tablets should inform their doctor and take them back to the pharmacy or place of purchase.

For more information, consumers can reach Lupin at (800) 399-2561.

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