Glenmark recalls 600mg Theophylline Extended-Release Tablets due to OOS dissolution test results. Rx-only medication with specific batch numbers and expiration dates.
OOS results reported for the Dissolution (by UV) test.
Glenmark is recalling certain Theophylline Extended-Release Tablets (600mg, 100 tablets) because lab tests showed inconsistent dissolution. This affects prescription-only medication with specific batch numbers and expiration dates.
The dissolution test measures how well the medication releases in the body. OOS (out of specification) results mean the tablets may not release the drug properly, potentially affecting treatment effectiveness. However, the recall does not specify a risk of injury or serious harm.
Prescription patients who have the recalled Theophylline tablets with batch numbers 19234121, 19234148 (expiring Sep 2025) or 19242881, 19242899 (expiring Jun 2026). Patients using these tablets for respiratory conditions may be at risk.
Check for batch numbers 19234121, 19234148 (expiring Sep 2025) or 19242881, 19242899 (expiring Jun 2026) on the product label. The product is a prescription-only medication with NDC 68462-356-01.
Look for batch numbers 19234121, 19234148 (expiring Sep 2025) or 19242881, 19242899 (expiring Jun 2026) on the tablet packaging.
The recall is due to lab test results showing inconsistent dissolution, but the official notice does not state a risk of injury or serious harm.
The recall does not specify a remedy, so no action is required beyond checking the product label for the batch numbers listed.
Check for batch numbers 19234121, 19234148 (expiring Sep 2025) or 19242881, 19242899 (expiring Jun 2026) on the product label.
We’ve drafted a message you can send Glenmark to request your refund or repair — edit it as you like.
Subject: Recall D-0452-2025 — Glenmark Glenmark Hello, I own a Glenmark that is covered by recall D-0452-2025 from Glenmark. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
