FDA Recall D-0124-2024

Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ

Class II Ongoing 919 days on record

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

Product

Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-188-01.

Lot / code: Lot# 19231903; Exp 4/2025 Lot# 19231858; Exp 4/2025 Lot# 19231881; Exp 4/2025 Lot# 19233484: Exp 8/2025 Lot# 19233490; Exp 8/2025

Reason for recall

Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen

Recall record

Recall number: D-0124-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide
Recall initiated: 2023-11-07
Classified by FDA Center: 2023-11-27
FDA published: 2023-12-06
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Firm location: Mahwah, NJ

Drug identification

Brand name(s): NAPROXEN SODIUM
Generic name(s): NAPROXEN SODIUM
Manufacturer(s): Glenmark Pharmaceuticals Inc., USA
NDC(s): 68462-178, 68462-188, 68462-189, 68462-190, 68462-179
Route(s): ORAL

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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