Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP) Recalled by Actavis Inc Due to Labeling: Incorrect or Missing Package Insert; Product is...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Actavis Inc directly.
Affected Products
Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet Dispensers per box, 28 Tablets Each, Rx Only, Manufactured for: Watson Pharm, Inc., a subsidiary of Watson Pharmaceutical, Inc., Corona, CA 92880, Manufactured by: Patheon, Inc., Mississauga, Ontario L9N7K9 Canada, NDC 52544-0949-28
Quantity: 511,283 Boxes
Why Was This Recalled?
Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Actavis Inc
Actavis Inc has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report