May 2025 FDA Recall Theophylline by Glenmark Pharmaceuticals Inc., Usa (D-0452-2025 - OOS results reported for the Dissolution (by UV) test.)

This Class II drug recall was voluntarily initiated by Glenmark Pharmaceuticals Inc., Usa on May 15, 2025 for the product Theophylline. The FDA reported the reason for recall as oos results reported for the dissolution (by uv) test.. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0452-2025

Reason for Recall
OOS results reported for the Dissolution (by UV) test.
Initiated
05-15-2025
Reported
06-04-2025
Quantity
8,520 100-count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96867
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

68462-380-01 Theophylline
68462-380-05 Theophylline
68462-356-01 Theophylline
68462-356-05 Theophylline