Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Norethindrone Acetate and Ethinyl Estradiol Tablets Recalled by Mylan Pharmaceuticals Inc. Due to Chemical Contamination: out of specification results for impurities...
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 Mylan Pharmaceuticals Inc. directly.
Affected Products
Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7280-85), packaged in 3 pouches, each contains one blister pack of 21 tablets (NDC 0378-7280-53), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India.
Quantity: 8,605 cartons
Why Was This Recalled?
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mylan Pharmaceuticals Inc.
Mylan Pharmaceuticals Inc. has 71 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report