FDA Recall D-0021-2026

Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ

Class II Ongoing 253 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28 Tablets, Rx only, 28 day Regimen, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA., Mahwah, NJ, 07430, NDC 68462-318-29.

Lot / code: Batch number 20230733, Exp Date: October 2025

Quantity: 26,928 packs

Reason for recall

Failed Impurities/Degradation Specifications

Recall record

Recall number: D-0021-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide.
Recall initiated: 2025-09-03
Classified by FDA Center: 2025-10-15
FDA published: 2025-10-22
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Firm location: Mahwah, NJ

Drug identification

Brand name(s): VIORELE
Generic name(s): DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
Manufacturer(s): Glenmark Pharmaceuticals Inc., USA
NDC(s): 68462-318

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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