CLASS II ONGOING Drug recall · Reported 24 Jun 2026 · FDA Enforcement Report
Alyacen 7/7/7, Norethindrone recalled by Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Inc., USA is recalling Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, distributed nationwide in the US. The recall was initiated on 27 May 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0588-2026
- FDA event ID
- 99101
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ
- Brand
- Alyacen 1/35
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 May 2026
- FDA classified
- 12 Jun 2026
- Reported
- 24 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Hormones & Birth Control
Timeline
| 27 May 2026 | Recall initiated by company | |
| 12 Jun 2026 | Classified by FDA | +16 days |
| 24 Jun 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Which lots are affected?
Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
Where was it sold?
USA Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Glenmark Pharmaceuticals Inc., USA
All 141| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azelaic Acid Gel, 15% tubes, For Topical Use only recalledAzelaic Acid | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalled | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Viorele, Desogestrel and Ethinyl Estradiol recalledViorele | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
Other Norethindrone recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Nortrel 7/7/7 (norethindrone recalled by Teva Pharmaceuticals USANortrel 7/7/7 | Teva Pharmaceuticals USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35 recalledNortrel | Teva Pharmaceuticals USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Balziva 28 Day (norethindrone recalled by Cardinal HealthBalziva | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS I | Taytulla Softgel Capsules, 1 mg/20 mcg recalled by Allergan, PLCTaytulla | Allergan | Other | Nationwide |
| Drug | CLASS III | Norethindrone Acetate and Ethinyl Estradiol Tablets recalledNorethindrone Acetate And Ethinyl Estradiol | Mylan Pharmaceuticals | Potency & Assay | Nationwide |