UnratedDrug recall · FDA · Published September 3, 2025
Glenmark Viorele and Ethinyl Estradiol Tablets Recall: Impurities Risk
Glenmark Pharmaceuticals recalls Viorele and Ethinyl Estradiol tablets due to failed impurities/degradation specs. These birth control pills may pose health risks if impurities are present. Check NDC 68462-318-29 and batch 20230733 for affected products.
“Glenmark Viorele and Ethinyl Estradiol Tablets Recall: Impurities Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31815-glenmark-viorele-and-ethinyl-estradiol-tablets-recall-impurities-risk. Based on FDA recall #D-0021-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0021-2026%22&limit=1).
The FDA announced on September 3, 2025, that Glenmark Pharmaceuticals Inc., USA is recalling Viorele, Desogestrel and Ethinyl Estradiol tablets due to failed impurity specifications. The voluntary Class II recall affects 26,928 packs distributed nationwide.
How to tell if you have it
Brand: Glenmark
Product: Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg
NDC: 68462-318-29
Batch number: 20230733
Exp Date: October 2025
The hazard
The recall is due to failed impurities and degradation specifications. The FDA classified the recall as Class II.
Context
GovInfoNow's records show Glenmark Pharmaceuticals Inc., USA has 54 other recalls on record since November 20, 2017. Other recent recalls of similar products include Glenmark Alyacen Birth Control Tablets Recall (May 27, 2026) and Lupin Ganirelix Acetate Injection Recall (November 13, 2025).
How to tell if you have this one
Check for the NDC code 68462-318-29 on the packaging. The batch number 20230733 and expiration date of October 2025 are also listed on the product.
Brand
Glenmark
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the NDC code 68462-318-29 and batch number 20230733 on the packaging to confirm if the product is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 49 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0021-2026 (September 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0021-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.