Oral contraceptive packs recalled after failing impurities and degradation specifications
Glenmark is recalling 26,928 packs of Viorele desogestrel and ethinyl estradiol tablets from one batch after the product failed impurities and degradation specifications.
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: Scored 2 as a specification failure: the record cites failed impurities and degradation specifications without naming the impurity, describing a health consequence, or reporting injury.
Plain-English summary
Viorele, containing Desogestrel and Ethinyl Estradiol USP 0.15 mg/0.02 mg and Ethinyl Estradiol USP 0.01 mg, supplied as three blisters of 28 tablets in a 28-day regimen and manufactured by Glenmark Pharmaceuticals Limited in Goa, India, is being recalled for failed impurities and degradation specifications.
The recall covers 26,928 packs from batch 20230733, expiring October 2025. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
The enforcement record states the specification failure without naming the impurity or describing a health consequence, and reports no injuries.
This is a prescription medicine taken on a daily schedule, so patients holding the affected batch should contact their pharmacy or prescriber about a replacement rather than stopping on their own.
The recalled product
- Product
- VIORELE (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL)
- Brand
- VIORELE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Contraceptive
- Affected units
- 26,928
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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