Theophylline recalls

Theophylline products have been recalled 3 times, most recently on 20 Aug 2025. The recalling company is usually Glenmark Pharmaceuticals Inc., U. The most common reason is potency & assay.

Total recalls3since 2021

Last 12 months0reported

Class I00% of total

Ongoing2latest 20 Aug 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 1 0Jul 1 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why theophylline is recalled

Potency & Assay267%
Manufacturing (CGMP) Deviations133%

Companies

Glenmark Pharmaceuticals Inc., U267%
Cardinal Health133%

By year

2025267%
2021133%

Ongoing theophylline recalls

2 active

Reported	Class	Recall	Company	Reason	Where
20 Aug 2025Drug	CLASS II	Theophylline extended-release tablets 400mg recalledTheophylline	Glenmark Pharmaceuticals Inc., U	Potency & Assay	Nationwide
4 Jun 2025Drug	CLASS II	Theophylline (Anhydrous) Extended-Release Tablets, 600 mg recalledTheophylline	Glenmark Pharmaceuticals Inc., U	Potency & Assay	Nationwide

All theophylline recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
20 Aug 2025Drug	CLASS II	Theophylline extended-release tablets 400mg recalledTheophylline	Glenmark Pharmaceuticals Inc., U	Potency & Assay	Nationwide
4 Jun 2025Drug	CLASS II	Theophylline (Anhydrous) Extended-Release Tablets, 600 mg recalledTheophylline	Glenmark Pharmaceuticals Inc., U	Potency & Assay	Nationwide
2 Jun 2021Drug	CLASS II	Theophylline (Anhydrous) Extended-Release Tablets 400 mg recalledTheophylline	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.