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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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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