FlaggedRx← Medication recall checkHome
Class II · ModerateActive recall

Theophylline

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLots: 19234121, 19234148, Exp Sep-30-25; Lots 19242881, 19242899, Exp Jun-30-26
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

OOS results reported for the Dissolution (by UV) test.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byGlenmark Pharmaceuticals Limited. Colvale-Bardez, Goa - 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430 foreign manufacturer
Brand nameTHEOPHYLLINE
Generic nameTHEOPHYLLINE
Active ingredient(s)THEOPHYLLINE ANHYDROUS
Distributed by / forGlenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430
NDC68462-356-01
Show the full FDA record
Full product labelTheophylline (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 firmGlenmark Pharmaceuticals Inc., USA
DistributionNationwide in the USA
Quantity8,520 100-count bottles
Recall initiated2025-05-15
Report date2025-06-04
Recall completed—
Recall numberD-0452-2025
ClassificationClass II
FDA statusOngoing
Origin on fileMahwah NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.