The FDA confirmed a nationwide recall (initiated May 27) of three strengths of Alyacen 7/7/7 birth control tablets made by Glenmark Pharmaceuticals. Affected lots are 20240411 (exp. 6/30/2026) and 20250252 (exp. 3/31/2027); the total number of doses was not disclosed. The recall cites "Failed Impurities/Degradation Specifications" and is classified as Class II, meaning adverse effects are expected to be temporary or medically reversible. Users should check their lot numbers and contact their healthcare provider for replacement options or guidance.
FDA Issues Nationwide Recall of Alyacen 7/7/7 Birth Control Tablets — Check Lot Numbers
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The U.S. Food and Drug Administration (FDA) confirmed a nationwide recall of three strengths of Alyacen 7/7/7 oral contraceptive tablets manufactured by Glenmark Pharmaceuticals. The agency published its report on June 12 and says the recall was initiated May 27.
Details of the Recall
Product: Alyacen 7/7/7 (Norethindrone and Ethinyl Estradiol Tablets) by Glenmark Pharmaceuticals (India and New Jersey operations).
Affected Strengths: 0.5 mg/0.035 mg, 0.75 mg/0.035 mg, and 1 mg/0.035 mg (combination dosages).
Lot Numbers and Expiration Dates: Lot 20240411 (Expires 6/30/2026) and Lot 20250252 (Expires 3/31/2027).
Packaging: Packages contain 3 blister cards, each with 28 tablets for a 28-day regimen.
Reason for Recall: The recall was initiated for "Failed Impurities/Degradation Specifications" — specifically, out-of-specification results for total impurities.
FDA Classification
The FDA classified this as a Class II recall. That classification indicates exposure to the affected product may cause temporary or medically reversible adverse health consequences, and the probability of serious adverse effects is considered remote.
What This Means For Users
If you use the pill for hormonal regulation (for example, to manage menstrual symptoms), this recall will often mean obtaining a replacement prescription from your clinician. If you rely on this medication to prevent pregnancy, contact your healthcare provider promptly to discuss alternatives and whether you should use a backup contraceptive method until you have a confirmed unaffected supply.
Do not stop or change your contraceptive routine without first consulting your provider or pharmacist.
Recommended Actions
- Check your medication: verify the brand, strength and lot number against the affected lots listed above.
- Contact your healthcare provider or pharmacist for guidance and to request a replacement prescription if you have an affected lot.
- Follow FDA or pharmacy instructions about returning or disposing of recalled medication.
- Report any adverse effects to your healthcare provider and consider filing a report with the FDA MedWatch program.
Note: The FDA report did not disclose the total number of affected doses. For the most current details and any updates, consult your healthcare provider or the FDA.
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