The Recall Desk
LowFDA (Drugs)·D-1439-2014·Announced 2014-07-23

Teva Recalls Velivet Birth Control Pills Due to Impurity Test Failures

Teva Pharmaceuticals is recalling 5,265 blister packs of Velivet birth control pills nationwide because impurity test results were out of specification.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Teva Pharmaceuticals USA is voluntarily recalling 5,265 blister packs of Velivet (desogestrel and ethinyl estradiol) tablets. The product is a triphasic oral contraceptive distributed nationwide. The specific lot affected is 33805449A, with an expiration date of 12/14.

The recall was initiated because the product failed impurities and degradation specifications, resulting in out-of-specification impurity test results. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers who have this specific lot of Velivet should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement. The recall is limited to the specific lot number and expiration date listed above.

The recalled product

Product
VELIVET (DESOGESTREL AND ETHINYL ESTRADIOL)
Brand
VELIVET
Hazard
Affected units
5,265

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot 33805449A
  • Exp. 12/14

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →