Glenmark Pharmaceuticals Inc., USA

Mahwah, NJ, United States

139

Total Recalls

2

Class I Recalls

109

Ongoing Recalls

Recalls by Glenmark Pharmaceuticals Inc., USA

FDA Drug Class II Ongoing

Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmac

March 13, 2025 Glenmark Pharmaceuticals Inc., USA N/A units
FDA Drug Class II Ongoing

Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Prades

March 13, 2025 Glenmark Pharmaceuticals Inc., USA N/A units
FDA Drug Class II Ongoing

chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-864-01

March 11, 2025 Glenmark Pharmaceuticals Inc., USA 8160 bottles units
FDA Drug Class II Ongoing

Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Gle

February 28, 2025 Glenmark Pharmaceuticals Inc., USA [100 Tablet Bottles] 59,952 bottles; [500 Tablet Bottles] 155,976 bottles units
FDA Drug Class II Ongoing

Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05.

February 28, 2025 Glenmark Pharmaceuticals Inc., USA 18,696 bottles units
FDA Drug Class II Ongoing

Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for: Glenmark Phar

February 28, 2025 Glenmark Pharmaceuticals Inc., USA [100 Tablet Bottles] 90,000 bottles; [500 Tablet Bottles] 324,288 bottles units
FDA Drug Class II Ongoing

Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430. NDC: 68462-164-05

February 28, 2025 Glenmark Pharmaceuticals Inc., USA 84,048 bottles units
FDA Drug Class II Ongoing

Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01.

January 29, 2025 Glenmark Pharmaceuticals Inc., USA 119,040 bottles units
FDA Drug Class II Ongoing

Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-270-30.

January 29, 2025 Glenmark Pharmaceuticals Inc., USA 87,600 bottles units
FDA Drug Class II Ongoing

Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-269-30.

January 29, 2025 Glenmark Pharmaceuticals Inc., USA 80,160 bottles units
FDA Drug Class II Ongoing

Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-761-01.

January 29, 2025 Glenmark Pharmaceuticals Inc., USA 58,368 bottles units
FDA Drug Class II Ongoing

Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.

January 29, 2025 Glenmark Pharmaceuticals Inc., USA 70,032 bottles units
FDA Drug Class II Ongoing

Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01.

January 29, 2025 Glenmark Pharmaceuticals Inc., USA 133,824 bottles units
FDA Drug Class II Ongoing

Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-266-30.

January 29, 2025 Glenmark Pharmaceuticals Inc., USA 56,208 bottles units
FDA Drug Class II Ongoing

Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-760-01.

January 29, 2025 Glenmark Pharmaceuticals Inc., USA 58,416 bottles units
FDA Drug Class II Ongoing

Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-267-30.

January 29, 2025 Glenmark Pharmaceuticals Inc., USA 175,920 bottles units
FDA Drug Class II Ongoing

Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-271-30.

January 29, 2025 Glenmark Pharmaceuticals Inc., USA 39,168 bottles units
FDA Drug Class II Ongoing

Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-759-01.

January 29, 2025 Glenmark Pharmaceuticals Inc., USA 53,952 bottles units
FDA Drug Class II Ongoing

Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-268-30.

January 29, 2025 Glenmark Pharmaceuticals Inc., USA 190,320 bottles units
FDA Drug Class II Ongoing

Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.

January 29, 2025 Glenmark Pharmaceuticals Inc., USA 120,000 bottles units
FDA Drug Class II Ongoing

Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-758-01.

January 29, 2025 Glenmark Pharmaceuticals Inc., USA 233,040 bottles units
FDA Drug Class II Ongoing

Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, Manufactured for Glenmark Pharmaceuticals, NJ.

January 22, 2025 Glenmark Pharmaceuticals Inc., USA
FDA Drug Class II Ongoing

Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured for Glenmark Pharmaceuticals, NJ.

January 22, 2025 Glenmark Pharmaceuticals Inc., USA
FDA Drug Class II Ongoing

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-862-01

December 11, 2024 Glenmark Pharmaceuticals Inc., USA
FDA Drug Class II Ongoing

chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ; Product of India, NDC 68462-861-01

December 11, 2024 Glenmark Pharmaceuticals Inc., USA 3,888 units
FDA Drug Class II Ongoing

Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pi

November 1, 2024 Glenmark Pharmaceuticals Inc., USA 7296 bottles units
FDA Drug Class II Ongoing

Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01.

November 1, 2024 Glenmark Pharmaceuticals Inc., USA 25584 bottles units
FDA Drug Class II Ongoing

Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01.

November 1, 2024 Glenmark Pharmaceuticals Inc., USA 12,864 bottles units
FDA Drug Class II Ongoing

Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of In

November 1, 2024 Glenmark Pharmaceuticals Inc., USA 34848 bottles units
FDA Drug Class II Ongoing

Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pi

November 1, 2024 Glenmark Pharmaceuticals Inc., USA 5232 bottles units
FDA Drug Class II Ongoing

Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pit

November 1, 2024 Glenmark Pharmaceuticals Inc., USA 4704 bottles units
FDA Drug Class III Ongoing

Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gm Tube, NDC 68462-0455-47; c) 100 gm Tube, NDC 68462-0455-94, Manufactured by: G

September 30, 2024 Glenmark Pharmaceuticals Inc., USA 11,568 tubes units
FDA Drug Class II Ongoing

Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bottle, 29 g net fill weight, Distr. by Hikma Specialty USA Inc., Columbus, OH 43

September 24, 2024 Glenmark Pharmaceuticals Inc., USA 45,504 bottles units
FDA Drug Class II Completed

Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, 07430,

August 30, 2024 Glenmark Pharmaceuticals Inc., USA 2,031,480 ointments units
FDA Drug Class II Ongoing

Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle (NDC 68462-325-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Lim

July 31, 2024 Glenmark Pharmaceuticals Inc., USA 2404 bottles units
FDA Drug Class II Ongoing

Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa, 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah

July 22, 2024 Glenmark Pharmaceuticals Inc., USA 14,004 cartons units
FDA Drug Class II Ongoing

Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Mad

June 28, 2024 Glenmark Pharmaceuticals Inc., USA a) 145,800 bottles; b) 1,368 bottles units
FDA Drug Class I Ongoing

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-D

May 30, 2024 Glenmark Pharmaceuticals Inc., USA 36,630 bottles units
FDA Drug Class II Ongoing

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-D

May 30, 2024 Glenmark Pharmaceuticals Inc., USA
FDA Drug Class II Ongoing

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-D

May 30, 2024 Glenmark Pharmaceuticals Inc., USA
FDA Drug Class I Ongoing

Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-D

May 30, 2024 Glenmark Pharmaceuticals Inc., USA 285,840 bottles units
FDA Drug Class II Ongoing

Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-468-06

May 13, 2024 Glenmark Pharmaceuticals Inc., USA 13296 cartons units
FDA Drug Class II Ongoing

Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-467-06

May 13, 2024 Glenmark Pharmaceuticals Inc., USA 2400 cartons units
FDA Drug Class II Ongoing

Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-466-99

May 10, 2024 Glenmark Pharmaceuticals Inc., USA 11,976 cartons units
FDA Drug Class II Ongoing

Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Product of India, NDC 68462-465-99

May 10, 2024 Glenmark Pharmaceuticals Inc., USA 3,480 cartons units
FDA Drug Class II Ongoing

Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of

April 17, 2024 Glenmark Pharmaceuticals Inc., USA 3,264 bottles units
FDA Drug Class II Ongoing

Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of

March 26, 2024 Glenmark Pharmaceuticals Inc., USA 6,528 bottles units
FDA Drug Class II Terminated

Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Village: Kishanpura, Baddi Nalagarh Road, District:

January 4, 2024 Glenmark Pharmaceuticals Inc., USA 38,496 bottles units
FDA Drug Class II Ongoing

Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, N

November 7, 2023 Glenmark Pharmaceuticals Inc., USA
FDA Drug Class II Ongoing

Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwa

November 7, 2023 Glenmark Pharmaceuticals Inc., USA 37,200 bottles units