Glenmark Pharmaceuticals Inc., USA 2025-06-04 Health serious FDA
Health · FDA · Recall #FDA-D-0452-2025
Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx… Recall
Issued June 4, 2025 · Glenmark Pharmaceuticals Inc., USA
In June 2025, Glenmark Pharmaceuticals Inc., USA recalled the Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
OOS results reported for the Dissolution (by UV) test.
What you should do
- 1 Stop using Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Glenmark Pharmaceuticals Inc., USA to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Glenmark Pharmaceuticals Inc., USA
- Category
- Health
- Recall date
- June 4, 2025
- Units affected
- Not reported
- Sold at
- Nationwide in the USA
- Recall number
- FDA-D-0452-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Glenmark Pharmaceuticals Inc., USA has 53 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.