Alyacen 7/7/7 0.5 mg/0.035mg Recall: Impurity Out of Spec
Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Alyacen 7/7/7 0.5 mg/0.035mg recalled?
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430, NDC 68462-556-29
Which lot codes, UPCs or models are affected?
Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
- Agency record number
- D-0588-2026
- Product
- Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28…
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Distribution
- USA Nationwide.
- Recall started
- May 27, 2026
- Report date
- June 24, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)