Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fayosim (levonorgestrel and ethinyl estradiol) tablets USP Recalled by Lupin Pharmaceuticals Inc. Due to Failed Impurities/Degradation Specifications: Out-of-specification results observed in related...
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 Lupin Pharmaceuticals Inc. directly.
Affected Products
Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP, (0.01 mg), packaged in 1 Extended-Cycle Wallet of 91 Tablets packed in a pouch(NDC 68180-860-11); one pouch per carton (NDC 68180-860-12), Rx only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.
Quantity: 12,464 cartons
Why Was This Recalled?
Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Lupin Pharmaceuticals Inc.
Lupin Pharmaceuticals Inc. has 119 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report