Home / Recalls / Glenmark Pharmaceuticals Inc., USA / D-0452-2025

D-0452-2025 Class II Ongoing

Recalled by Glenmark Pharmaceuticals Inc., USA — Mahwah, NJ

Recall Details

Product Type
Drugs
Report Date
June 4, 2025
Initiation Date
May 15, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,520 100-count bottles

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

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

Lots: 19234121, 19234148, Exp Sep-30-25; Lots 19242881, 19242899, Exp Jun-30-26

Other recalls by Glenmark Pharmaceuticals Inc., USA

  • D-0246-2026 Class II — Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards (December 30, 2025)
  • D-0199-2026 Class III — Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packag (November 21, 2025)
  • D-0222-2026 Class III — Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmac (November 18, 2025)
  • D-0662-2025 Class II — Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: (September 17, 2025)
  • D-0021-2026 Class II — Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Es (September 3, 2025)
  • D-0583-2025 Class II — Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufact (August 8, 2025)
  • D-0577-2025 Class II — Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-16 (August 7, 2025)
  • D-0579-2025 Class II — Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glen (August 7, 2025)
  • D-0578-2025 Class II — Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Gl (August 7, 2025)
  • D-0587-2025 Class II — Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured (August 6, 2025)