The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-681-2013·Announced 2013-07-17

Teva Recalls Lessina Oral Contraceptives Due to Impurity Detection

Teva Pharmaceuticals is recalling Lessina oral contraceptives because an impurity was detected during testing. The FDA classifies this as a Class III recall.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

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

Our severity reasoning: The FDA classified this as a Class III recall, 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, Inc. is recalling 148,785 blister packs of Lessina (levonorgestrel and ethinyl estradiol) tablets. The recall was initiated because an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing. The affected product is a prescription-only medication with a 28-day regimen, manufactured by Barr Laboratories Inc. in Pomona, NY.

The recall covers specific lot numbers with expiration dates ranging from August 2013 to March 2014. The product was distributed nationwide, with no foreign or government accounts involved. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers and healthcare providers should stop using the affected lots and return them to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative contraceptive options if necessary.

The recalled product

Product
LESSINA (LEVONORGESTREL AND ETHINYL ESTRADIOL)
Brand
LESSINA
Manufacturer
Teva Pharmaceuticals USA, Inc.
Category
Drug — Oral Contraceptive
Hazard
Affected units
148,785

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 (9)

  • NDC 0555-9014-67
  • Lot numbers 33802921A
  • exp 8/2013
  • 33803173A
  • exp 10/2013
  • 33803695A
  • exp 2/2014
  • and 33803942A
  • exp 3/2014.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Teva Pharmaceuticals USA, Inc. 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 →

Related recalls

Same manufacturer · Teva Pharmaceuticals USA, Inc.

See all →

Same hazard · impurity

See all →

Similar recalls