Glenmark Alyacen 7/7/7 contraceptive recalled for impurities
Glenmark Pharmaceuticals is recalling specific lots of Alyacen 7/7/7 (a birth control pill) because testing found higher-than-allowed impurity levels in the tablets. The affected lots were distributed nationwide. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Glenmark recalls
What to do
- Check if your Alyacen 7/7/7 matches lot #20240411 (expires 6/30/2026) or lot #20250252 (expires 3/31/2027).
- If you have an affected lot, contact your pharmacy or prescriber before stopping the medication.
- Do not stop taking your birth control without talking to your doctor first, as this could affect contraceptive protection.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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 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
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Illnesses reported
- None reported
- Manufactured in
- 619 River Dr, Elmwood Park, NJ, United States
- Classification
- Class II
- Recall number
- D-0588-2026
In the FDA's words
- 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 Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities. Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027 Distribution: USA Nationwide.
- Hazard
- Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
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