Alyacen 7/7/7 recall
FDA recall D-0588-2026 · initiated May 27, 2026
Glenmark Pharmaceuticals Inc., USA recalled Alyacen 7/7/7 in May 2026 — an FDA Class II recall (D-0588-2026) because Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Details
- 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
- Recalling company
- Glenmark Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide.
- Initiated
- May 27, 2026
- FDA report date
- Jun 24, 2026
Frequently asked
- Was Alyacen 7/7/7 recalled?
- Glenmark Pharmaceuticals Inc., USA recalled Alyacen 7/7/7 in May 2026 — an FDA Class II recall (D-0588-2026) because Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Alyacen 7/7/7 recalled?
- Per the FDA enforcement record, the reason for recall D-0588-2026 was: Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
- Is a recalled Alyacen 7/7/7 dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Alyacen 7/7/7 are affected?
- Distributed: USA Nationwide.. The recall covers these lots — Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0588-2026.