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Drug company (FDA labeler)

Major Pharamceuticals

NDC labeler code: 0904

What is a labeler?

The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.

Official FDA data only

Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.

Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.

At a glance

1Prescription medicines
1Products (NDC)
1FDA applications
48Recalls

Prescription medicines

FDA applications for these products

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
ApprovedApplicationMedicineSponsor
November 30, 2000ANDA065062 Minocycline hydrochloride
MINOCYCLINE HYDROCHLORIDE		Torrent

The sponsor is the company that holds the FDA application; it can differ from the labeler.

Recall timeline

2026

  1. July 16, 2026 · Class III · Ongoing · D-0737-2026 · Dabigatran etexilate

    Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

    Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN

  2. July 16, 2026 · Class III · Ongoing · D-0738-2026 · Dabigatran etexilate

    Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

    Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46

  3. July 16, 2026 · Class III · Ongoing · D-0739-2026 · Dabigatran etexilate

    Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

    Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 4

  4. July 13, 2026 · Class II · Ongoing · D-0708-2026 · Levothyroxine

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal He

  5. July 13, 2026 · Class II · Ongoing · D-0700-2026 · Levothyroxine

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6949-61

  6. July 13, 2026 · Class II · Ongoing · D-0702-2026 · Levothyroxine

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61

  7. July 13, 2026 · Class II · Ongoing · D-0705-2026 · Levothyroxine

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6955-61

  8. July 13, 2026 · Class II · Ongoing · D-0703-2026 · Levothyroxine

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6952-61

  9. July 13, 2026 · Class II · Ongoing · D-0706-2026 · Levothyroxine

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6956-61

  10. July 13, 2026 · Class II · Ongoing · D-0701-2026 · Levothyroxine

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6950-61

Show the 38 older recalls

2026

  1. July 13, 2026 · Class II · Ongoing · D-0709-2026 · Levothyroxine

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal He

  2. July 13, 2026 · Class II · Ongoing · D-0707-2026 · Levothyroxine

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal He

  3. July 13, 2026 · Class II · Ongoing · D-0711-2026 · Levothyroxine

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal

  4. July 13, 2026 · Class II · Ongoing · D-0704-2026 · Levothyroxine

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6954-61

  5. July 13, 2026 · Class II · Ongoing · D-0710-2026 · Levothyroxine

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal

  6. June 30, 2026 · Class III · Ongoing · D-0735-2026 · Dabigatran etexilate

    Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.

    Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.

  7. June 30, 2026 · Class III · Ongoing · D-0736-2026 · Dabigatran etexilate

    Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.

    Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.

  8. June 16, 2026 · Class II · Ongoing · D-0609-2026 · Methylergonovine maleate

    Subpotent Drug

    Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, in 46268, NDC 0904-7282-10. Blister Label: Methylergonov

  9. April 9, 2026 · Class II · Ongoing · D-0493-2026 · OMEGA-3-ACID ethyl esters

    Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.

    Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06

  10. March 24, 2026 · Class II · Ongoing · D-0485-2026 · Memantine hydrochloride

    Failed Dissolution Specifications

    Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61

  11. February 17, 2026 · Class II · Ongoing · D-0383-2026 · Midodrine hydrochloride

    Defective container; inadequately sealed blister packaging.

    Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06.

2025

  1. October 10, 2025 · Class II · Ongoing · D-0031-2026 · Gabapentin

    Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

    Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag)

  2. October 10, 2025 · Class II · Ongoing · D-0030-2026 · Gabapentin

    Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

    Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61

  3. September 2, 2025 · Class II · Ongoing · D-0624-2025 · Sulfamethoxazole and trimethoprim

    Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

    Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC

  4. September 2, 2025 · Class II · Ongoing · D-0625-2025 · Sulfamethoxazole and trimethoprim

    Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

    Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-7895-0 (Outer Bag) containing

  5. August 20, 2025 · Class II · Ongoing · D-0594-2025 · Carvedilol

    CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

    Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61

  6. June 19, 2025 · Class II · Ongoing · D-0507-2025 · Gabapentin

    Defective container; blister packaging inadequately sealed.

    Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61

  7. January 30, 2025 · Class II · Ongoing · D-0221-2025 · Potassium chloride

    Failed Dissolution Specifications.

    Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ

2023

  1. May 31, 2023 · Class I · Terminated · D-0893-2023 · Ziprasidone

    Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.

    ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally-500 090 India, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-6

  2. April 24, 2023 · Class III · Terminated · D-0570-2023 · Gabapentin

    Product mixup: one foreign tablet found in product.

    Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 1717

2022

  1. April 13, 2022 · Class II · Terminated · D-1059-2022 · Sulfamethoxazole and trimethoprim

    cGMP deviations: Temperature abuse

    Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-2725-61

  2. April 13, 2022 · Class II · Terminated · D-1055-2022 · Ibuprofen

    cGMP deviations: Temperature abuse

    Ibuprofen Tablets USP, 400 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-5853-61

  3. April 13, 2022 · Class II · Terminated · D-1054-2022 · Doxycycline

    cGMP deviations: Temperature abuse

    Doxycycline Hyclate Tablets, USP, 100 mg, 50-count carton (10 tablets each blister pack x 5), Rx only, MFG: Major Pharma, NDC 0904-0430-06

  4. April 13, 2022 · Class II · Terminated · D-1088-2022 · Levofloxacin

    cGMP deviations: Temperature abuse

    Levofloxacin Tablets, 500 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6352-61

  5. February 28, 2022 · Class II · Terminated · D-0649-2022 · Paliperidone

    Failed Dissolution Specifications

    PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, India. Distributed by: MAJOR PH

2021

  1. August 6, 2021 · Class II · Terminated · D-0807-2021 · Carbamazepine

    Failed Dissolution Specifications

    Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd., Bharuch-392130, India; Manufactured for: Torrent Pharma, Inc., Basking Ridge, NJ 07920; Distr

  2. July 29, 2021 · Class II · Terminated · D-0806-2021 · Entacapone

    Failed Dissolution Specifications

    Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC 0904-6822-04

  3. July 2, 2021 · Class II · Terminated · D-0652-2021 · Nifedipine

    Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.

    NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 50 count unit dose carton, NDC 0904-7080-06: Distributed by: Ingenus Pharmaceuticals, LLC Orlando, FL

  4. March 15, 2021 · Class II · Terminated · D-0510-2021 · Trazodone hydrochloride

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    TRAZODONE HYDROCHLORIDE TABLETS, USP 50MG 100 TABLET 10X10UD; NDC/UPC 0904-6868-61; RX; TABLETS

2020

  1. May 22, 2020 · Class II · Terminated · D-1288-2020 · Doxycycline

    Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.

    Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit dose carton (NDC 0904-0430-06), Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; Distribu

  2. February 27, 2020 · Class III · Terminated · D-1002-2020 · Quetiapine

    Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

    Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park

  3. February 27, 2020 · Class III · Terminated · D-1001-2020 · Quetiapine

    Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

    Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park

  4. February 27, 2020 · Class III · Terminated · D-0999-2020 · Quetiapine

    Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

    Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park D

  5. February 27, 2020 · Class III · Terminated · D-1000-2020 · Quetiapine

    Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

    Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park

2019

  1. April 24, 2019 · Class II · Terminated · D-1583-2019 · Divalproex sodium

    cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.

    DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177

2018

  1. July 30, 2018 · Class II · Terminated · D-1026-2018 · Doxycycline

    Failed Dissolution Specifications

    Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NY 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Sui

2017

  1. January 5, 2017 · Class II · Terminated · D-0689-2017 · Fluconazole

    Failed Dissolution Specifications

    Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI

  2. January 5, 2017 · Class II · Terminated · D-0688-2017 · Fluconazole

    Failed Dissolution Specifications

    Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

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