Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
2 recalls
-
Class II Ongoing
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, N…
Reason: 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.
Lots, distribution and details
- Product
- Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ, NDC 68462-380-01
- Lots / codes
- Batch # 19243193, 19243215, 19243231,19243248, 19243283, Exp 7/31/2026; 19244530, 19244561, Exp 10/31/2026; 19250178, Exp 12/31/2026
- Distribution
- USA nationwide.
- Quantity
- 22,656 bottles
- Recall started
- August 8, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0583-2025
-
Class II Ongoing
Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa – 403513, India. Manufactured for: Glenmark Pharmaceutica…
Reason: OOS results reported for the Dissolution (by UV) test.
Lots, distribution and details
- Product
- Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited. Colvale-Bardez, Goa – 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-356-01
- Lots / codes
- Lots: 19234121, 19234148, Exp Sep-30-25; Lots 19242881, 19242899, Exp Jun-30-26
- Distribution
- Nationwide in the USA
- Quantity
- 8,520 100-count bottles
- Recall started
- May 15, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0452-2025
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.