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.
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: 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.
Related recalls
Same manufacturer · Glenmark Pharmaceuticals Inc., USA
See all →- ModerateAzelaic Acid Gel 15% Recalled Over Grainy, Gritty, or Sandy Texture
FDA (Drugs) · 2026-08-05
- ModerateAlyacen 7/7/7 birth control tablets failed total impurities specification
FDA (Drugs) · 2026-06-24
- ModerateOndansetron tablets recalled because blister packs are not fully sealed
FDA (Drugs) · 2026-01-07
- CriticalFrozen chopped methi recalled after testing positive for Salmonella
FDA (Drugs) · 2025-12-17
- ModerateBisoprolol and hydrochlorothiazide tablets recalled over traces of another drug
FDA (Drugs) · 2025-12-10
Same hazard · impurity
See all →- ModerateAjanta Pharma Recalls Fluphenazine Hydrochloride Tablets Due to Impurity Failure
FDA (Drugs) · 2026-09-16
- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
Similar recalls
- LowTeva Recalls APRI Oral Contraceptive Tablets Due to Impurity Test Failures
FDA (Drugs) · 2014-07-23
- LowTeva Recalls Velivet Birth Control Pills Due to Impurity Test Failures
FDA (Drugs) · 2014-07-23
- ModerateAlyacen 7/7/7 birth control tablets failed total impurities specification
FDA (Drugs) · 2026-06-24
- ModerateTeva Recalls Kariva Tablets Due to Out-of-Specification Impurity Test Results
FDA (Drugs) · 2014-07-23
- LowTeva Recalls Lessina Oral Contraceptives Due to Impurity Detection
FDA (Drugs) · 2013-07-17
- LowTeva Recalls Portia Tablets Due to Appearance Specification Failures
FDA (Drugs) · 2013-04-17