Alyacen 7/7/7 birth control tablets failed total impurities specification
Alyacen 7/7/7 norethindrone and ethinyl estradiol tablets are being recalled because of out-of-specification results for total impurities.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for an out-of-specification impurities result with no named impurity or clinical consequence described, which fits the Moderate band.
Plain-English summary
Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/0.035 mg, 0.75 mg/0.035 mg and 1 mg/0.035 mg, supplied as three blister cards of 28 tablets for a 28-day regimen, prescription only, manufactured by Glenmark Pharmaceuticals Ltd., is being recalled.
The stated reason is failed impurities and degradation specifications: the recall was initiated due to out-of-specification results for total impurities. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Affected lots are 20240411 (expiring 6/30/2026) and 20250252 (expiring 3/31/2027). Distribution was USA nationwide.
Patients should not stop taking a prescribed medicine without advice. Anyone holding an affected lot should speak to their pharmacist or prescriber and follow the instructions issued by the firm.
The recalled product
- Product
- ALYACEN 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL)
- Brand
- ALYACEN 1/35
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Oral contraceptive
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 20240411
- Exp: 6/30/2026
- 20250252
- Exp: 3/31/2027
UPCs (3)
- 0368462394847
- 0368462394298
- 0368462556849
Distribution
Distributed nationwide across the United States.
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