Theophylline recalls

The FDA has published 3 recalls involving Theophylline since 2021. The latest was reported on 20 Aug 2025. Most were for potency & assay. Glenmark Pharmaceuticals Inc., U has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

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

Should you stop taking Theophylline?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.