Glenmark Pharmaceuticals Inc., USA: 131 recalls on record

Recalls filed with 1 agency: FDA (131).

First recall on record: February 7, 2018. Most recent: August 5, 2026.

Risk classification: Class I: 2 · Class II: 118 · Class III: 11

Most recent recalls

DateAgencyProduct
August 5, 2026FDAAzelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glen…D-0731-2026
June 24, 2026FDAAlyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.0…D-0588-2026
January 7, 2026FDAOndansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each cont…D-0246-2026
December 17, 2025FDANebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals …D-0222-2026
December 10, 2025FDABisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a)…D-0199-2026
October 22, 2025FDAViorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol T…D-0021-2026
October 1, 2025FDAAzelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark…D-0662-2025
August 20, 2025FDACarvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmar…D-0588-2025
August 20, 2025FDACarvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Phar…D-0579-2025
August 20, 2025FDATheophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: …D-0583-2025
August 20, 2025FDACarvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) …D-0577-2025
August 20, 2025FDACarvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenm…D-0587-2025
August 20, 2025FDACarvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Ph…D-0578-2025
June 18, 2025FDAEzetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: …D-0462-2025
June 4, 2025FDACarvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-c…D-0448-2025
June 4, 2025FDACarvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharm…D-0451-2025
June 4, 2025FDACarvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Phar…D-0450-2025
June 4, 2025FDATheophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Onl…D-0452-2025
June 4, 2025FDACarvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bot…D-0449-2025
April 16, 2025FDARanolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: …D-0335-2025
April 16, 2025FDANitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: Glenmark Phar…D-0331-2025
April 16, 2025FDAPravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx…D-0349-2025
April 16, 2025FDAPropafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Manuf…D-0316-2025
April 16, 2025FDAGabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceu…D-0320-2025
April 16, 2025FDAColesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glen…D-0340-2025

Questions about this company

How many recalls does Glenmark Pharmaceuticals Inc., USA have?
Recalert has 131 U.S. recalls on record for Glenmark Pharmaceuticals Inc., USA, published between February 7, 2018 and August 5, 2026.
What was the most recent Glenmark Pharmaceuticals Inc., USA recall?
FDA recall D-0731-2026, published August 5, 2026: Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52.
Which agencies have handled Glenmark Pharmaceuticals Inc., USA recalls?
Glenmark Pharmaceuticals Inc., USA appears as the recalling firm in recalls from: FDA (131).

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