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Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg Recall 2026

ALYACEN 1/35Issued May 27, 2026Updated Reviewed by the Recall Watch editorial team

ALYACEN 1/35 Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glen — recalled per FDA on 5/27/2026. Reason: Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities..

Agency
FDA
Issued
May 27, 2026
Brand
ALYACEN 1/35
Distribution
1 states
Lots affected
4
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued May 27, 2026 · Last synced Nov 1, 2026

What's recalled

Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430, NDC 68462-556-29

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Why it was recalled

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

Affected products & lot numbers
4 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot #: 20240411
Exp: 6/30/2026
20250252
Exp: 3/31/2027
Where was it sold
1 state

USA Nationwide.

nationwide
Official noticefda.gov
More recalls like this
4 related — by brand, contaminant, and category

Frequently asked questions

Is the ALYACEN 1/35 recall still active?

Yes, this recall is currently active as of May 27, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot #: 20240411, Exp: 6/30/2026, 20250252, Exp: 3/31/2027. Check the label on your product.

What should I do if I have the recalled ALYACEN 1/35?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.