The Recall Desk
HighFDA (Drugs)·D-0588-2026·Announced 2026-06-24

[pending] ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL)

Pending LLM rewrite. Source: FDA_DRUG D-0588-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.

The recalled product

Product
ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL)
Brand
ALYACEN 1/35
Manufacturer
Glenmark Pharmaceuticals Inc., USA

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot #: 20240411
  • Exp: 6/30/2026
  • 20250252
  • Exp: 3/31/2027

UPCs (3)

  • 0368462394847
  • 0368462394298
  • 0368462556849

Distribution

Distributed nationwide across the United States.