Lower riskDrug recall · FDA · Published May 27, 2026
Glenmark Alyacen Birth Control Tablets Recall: Impurities Risk
Glenmark Pharmaceuticals recalls Alyacen birth control tablets with impurities. These pills may have unsafe levels of impurities that could affect safety. Stop using if you have the specific lot numbers listed.
“Glenmark Alyacen Birth Control Tablets Recall: Impurities Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/31286-glenmark-alyacen-birth-control-tablets-recall-impurities-risk. Based on FDA recall #D-0588-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0588-2026%22&limit=1).
The FDA announced on May 27, 2026, that Glenmark Pharmaceuticals Inc., USA is recalling Alyacen 7/7/7 tablets due to failed impurity specifications. Owners should contact the company for a refund.
How to tell if you have it
Brand: Glenmark
Product: Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP
Packaging: 3 Blister Cards each containing 28 tablets
NDC: 68462-556-29
Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
Distribution: USA Nationwide
The hazard
The recall is due to out-of-specification results for total impurities in the tablets. The FDA's FAERS database contains 244 adverse-event reports naming this product, including 137 serious cases and 8 deaths, though these are unverified reports not linked directly to the recall.
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 Azelaic Acid Gel 15% Recall (July 23, 2026), Glenmark Ondansetron Tablets Recall (December 30, 2025), and Glenmark Bisoprolol/Hydrochlorothiazide Tablets Recall (November 21, 2025). Other recent recalls of similar products include Ajanta Pharma Fluphenazine Tablets Recall (August 25, 2026), Lupin Ganirelix Acetate Injection Recall (November 13, 2025), and Sagent Busulfan Injection Recall (May 4, 2026).
How to tell if you have this one
Check the lot number on the blister pack: 20240411 (expires 6/30/2026) or 20250252 (expires 3/31/2027). These are the only affected batches.
Brand
Glenmark
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Look for the lot number on the blister pack: 20240411 or 20250252.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “USA 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 28 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-0588-2026 (May 27, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0588-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.