May 2026 FDA Recall Alyacen 1/35 by Glenmark Pharmaceuticals Inc., Usa
D-0588-2026 - Failed Impurities/Degradation Specifications
This Class II drug recall was voluntarily initiated by Glenmark Pharmaceuticals Inc., Usa on May 27, 2026 for the product Alyacen 1/35. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0588-2026
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
05-27-2026
06-24-2026
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
