Viorele contraceptive recalled for failed impurity and degradation specifications
Glenmark Pharmaceuticals is recalling 26,928 packs of Viorele contraceptive nationwide due to failed impurities and degradation specifications in batch 20230733.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA classified this as a Class II drug recall with no reported illnesses or injuries. The failed impurity and degradation specifications on a prescription contraceptive represent a theoretical risk of harm to users.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Viorele (Desogestrel and Ethinyl Estradiol), a prescription oral contraceptive, due to failed impurities and degradation specifications in manufacturing. The recalled batch is number 20230733 with an expiration date of October 2025, affecting 26,928 packs distributed nationwide in the United States.
Users of Viorele from the affected batch should contact their healthcare provider to confirm whether they received recalled medication and to discuss options regarding their contraceptive coverage. Consumers should not discontinue use without consulting their healthcare provider.
The FDA classified this as a Class II recall. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL)
- Brand
- VIORELE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Oral Contraceptive
- Hazard
- impurity
- degradation
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 (2)
- Batch number 20230733
- Exp Date: October 2025
Distribution
Distributed nationwide across the United States.
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