Teva Recalls Jolessa Birth Control Tablets Due to Impurity Detection
Teva Pharmaceuticals is recalling specific lots of Jolessa birth control tablets because an impurity was detected during testing.
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 recall is classified as FDA 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, Inc. is recalling 54,412 blister packs of Jolessa (levonorgestrel/ethinyl estradiol) tablets. The recall involves NDC 0555-9123-66 and specific lot numbers with expiration dates in 2013. The product was distributed nationwide.
The recall was initiated because an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing. This is classified as an FDA Class III recall, which indicates the product is not likely to cause adverse health consequences.
Consumers should check their medication for the specific NDC and lot numbers listed in the recall notice. If the product matches the recalled lots, they should contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- JOLESSA (LEVONORGESTREL / ETHINYL ESTRADIOL)
- Brand
- JOLESSA
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Category
- Drug — Oral Contraceptive
- Hazard
- Affected units
- 54,412
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 (7)
- NDC 0555-9123-66
- Lot numbers 33802986A
- exp 9/2013
- 33802991A
- exp 7/2013
- and 33803270A
- exp 10/2013.
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
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