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Class II · ModerateActive recall

Viorele

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberBatch number 20230733, Exp Date: October 2025
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Impurities/Degradation Specifications

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byGlenmark Pharmaceuticals Limited, Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA., Mahwah, NJ, 07430 foreign manufacturer
Brand nameVIORELE
Generic nameDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
Distributed by / forGlenmark Pharmaceuticals Inc., USA., Mahwah, NJ, 07430
NDC68462-318-29
Show the full FDA record
Full product labelViorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28 Tablets, Rx only, 28 day Regimen, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA., Mahwah, NJ, 07430, NDC 68462-318-29.
Recalling firmGlenmark Pharmaceuticals Inc., USA
DistributionUS Nationwide.
Quantity26,928 packs
Recall initiated2025-09-03
Report date2025-10-22
Recall completed—
Recall numberD-0021-2026
ClassificationClass II
FDA statusOngoing
Origin on fileMahwah NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.