Reported Aug 20, 2025 · Ongoing
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals…
Glenmark Pharmaceuticals Inc., USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Glenmark Pharmaceuticals Inc., USA · 750 Corporate Dr · Mahwah, NJ · 07430-2009
Is this the product you have?
Theophylline extended-release tablets 400mg100-count bottleRx only
- Manufactured byGlenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India
- Manufactured forGlenmark Pharmaceuticals Inc. USA, Mahwah, NJ, NDC 68462-380-01
- Lot codes and dates
Batch # 1924319319243215192432311924324819243283Exp 7/31/20261924453019244561Exp 10/31/202619250178Exp 12/31/2026
- Amount recalled
- 22,656 bottles
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
This product could cause temporary or reversible health problems — stop using it.
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