The Recall Desk
HighFDA (Drugs)·D-0452-2025·Announced 2025-06-04

[pending] THEOPHYLLINE (THEOPHYLLINE)

Pending LLM rewrite. Source: FDA_DRUG D-0452-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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

The recalled product

Product
THEOPHYLLINE (THEOPHYLLINE)
Brand
THEOPHYLLINE
Manufacturer
Glenmark Pharmaceuticals Inc., USA

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 (6)

  • Lots: 19234121
  • 19234148
  • Exp Sep-30-25
  • Lots 19242881
  • 19242899
  • Exp Jun-30-26

UPCs (2)

  • 0368462380017
  • 0368462356012

Distribution

Distributed nationwide across the United States.