Drug recall
Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by…
FDA recall event 96867 · Class II · Glenmark Pharmaceuticals Inc., USA
Key facts
| Event ID | 96867 |
|---|---|
| Recall numbers | D-0452-2025 |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA |
| Product type | Drugs |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | OOS results reported for the Dissolution (by UV) test. |
| Initiation date | May 15, 2025 |
| Report date | Jun 4, 2025 |
| City | Mahwah |
| State | NJ |
| Country | United States |
| FEI number | 3005658103 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: