Theophylline (Anhydrous) Extended-Release Tablets recall
FDA recall D-0452-2025 · initiated May 15, 2025
Glenmark Pharmaceuticals Inc., USA recalled Theophylline (Anhydrous) Extended-Release Tablets in May 2025 — an FDA Class II recall (D-0452-2025) because OOS results reported for the Dissolution (by UV) test.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
OOS results reported for the Dissolution (by UV) test.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 8,520 100-count bottles
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
- Recalling company
- Glenmark Pharms
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- May 15, 2025
- FDA report date
- Jun 4, 2025
Frequently asked
- Was Theophylline (Anhydrous) Extended-Release Tablets recalled?
- Glenmark Pharmaceuticals Inc., USA recalled Theophylline (Anhydrous) Extended-Release Tablets in May 2025 — an FDA Class II recall (D-0452-2025) because OOS results reported for the Dissolution (by UV) test. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Theophylline (Anhydrous) Extended-Release Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0452-2025 was: OOS results reported for the Dissolution (by UV) test.
- Is a recalled Theophylline (Anhydrous) Extended-Release Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Theophylline (Anhydrous) Extended-Release Tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lots: 19234121, 19234148, Exp Sep-30-25; Lots 19242881, 19242899, Exp Jun-30-26. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0452-2025.