Reported Jun 4, 2025 · Ongoing
Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark…
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 (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only
- Manufactured byGlenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India
- Manufactured forGlenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430
- NDC68462-356-01
- Lot codes and dates
- Lots
1923412119234148Exp Sep-30-25Lots 1924288119242899Exp Jun-30-26
- Lots
- Amount recalled
- 8,520 100-count bottles
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
OOS results reported for the Dissolution (by UV) test.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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