FDA recall, , Moderate risk
Glenmark Alyacen 7/7/7 and Norethindrone and Ethinyl Estradiol Tablets
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Summary by Recall Canary from the FDA notice
What happened
Glenmark Pharmaceuticals Inc., USA, of Elmwood Park, New Jersey, recalled Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, a 28-day regimen with 3 blister cards of 28 tablets, because out-of-specification results for total impurities failed impurities/degradation specifications. The recall began May 27, 2026, and was added to the FDA's Enforcement Report on June 12, 2026. The product was distributed nationwide in the USA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Affected if its NDC or UPC is listed.
A UPC is the number printed under a barcode. An NDC (National Drug Code) is usually printed on the drug's label.
Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP
- NDC
- 68462-556-29
- UPC
- 20240411
- 20250252
Recall details
- Company began the recall
- Sold in
USA Nationwide.
- Company
- Glenmark Pharmaceuticals Inc., USAElmwood Park, New Jersey
- Hazard
- Drug impurity
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99101
- Recall number
- D-0588-2026
All recalls from Glenmark Pharmaceuticals Inc., USA
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
