Why it was recalled
OOS results reported for the Dissolution (by UV) test.
Product description
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
Lot numbers, UPCs & expiration codes
Lots: 19234121, 19234148, Exp Sep-30-25; Lots 19242881, 19242899, Exp Jun-30-26
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0452-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 15, 2025
- FDA report date
- Jun 4, 2025
- Quantity
- 8,520 100-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0452-2025, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96867
- Address
- 750 Corporate Dr
- Code information
- Lots: 19234121, 19234148, Exp Sep-30-25; Lots 19242881, 19242899, Exp Jun-30-26
- Postal code
- 07430-2009
- Report date
- Jun 4, 2025
- Product type
- Drugs
- Recall number
- D-0452-2025
- Classification
- Class II
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 8,520 100-count bottles
- Reason for recall
- OOS results reported for the Dissolution (by UV) test.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 15, 2025
- Initial firm notification
- Letter
- Center classification date
- May 28, 2025