FDA Recall D-0452-2025

Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ

Class II Ongoing 364 days on record

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

Product

Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-356-01

Lot / code: Lots: 19234121, 19234148, Exp Sep-30-25; Lots 19242881, 19242899, Exp Jun-30-26

Quantity: 8,520 100-count bottles

Reason for recall

OOS results reported for the Dissolution (by UV) test.

Recall record

Recall number: D-0452-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2025-05-15
Classified by FDA Center: 2025-05-28
FDA published: 2025-06-04
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Firm location: Mahwah, NJ

Drug identification

Brand name(s): THEOPHYLLINE
Generic name(s): THEOPHYLLINE
Manufacturer(s): Glenmark Pharmaceuticals Inc., USA
NDC(s): 68462-356, 68462-380
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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