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Drug company (FDA labeler)

BluePoint Labortories

NDC labeler code: 68001

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
3Products (NDC)
1FDA applications
12Recalls

Prescription medicines

FDA applications for these products

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
ApprovedApplicationMedicineSponsor
February 16, 2016ANDA201722 Nitrofurantoin
NITROFURANTOIN		Sun Pharm Industries

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

Recall timeline

2025

  1. April 2, 2025 · Class II · Ongoing · D-0369-2025 · Haloperidol decanoate

    Lack of assurance of sterility. Bacterial contamination detected in some media fill units

    Haloperidol Decanoate Injection, 100mg/mL*, 5 x 1 mL Single-Dose Vials, Rx Only, Manufactured by: Somerset Therapeutics Limited, #54/1 Boodhihal Village, Nelamangala, Bangalore -562123, Karnataka, India, Manufactured for

  2. April 2, 2025 · Class II · Ongoing · D-0368-2025 · Haloperidol decanoate

    Lack of assurance of sterility. Bacterial contamination detected in some media fill units

    Haloperidol Decanoate Injection, 100 mg/mL*, 1 x 1 mL Single-Dose Vial, Rx only, Manufactured by: Somerset Therapeutics Limited, #54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured f

  3. April 2, 2025 · Class II · Ongoing · D-0367-2025 · Haloperidol decanoate

    Lack of assurance of sterility. Bacterial contamination detected in some media fill units

    Haloperidol Decanoate Injection, 50mg/mL* , 1 mL Single-Dose Vial, Rx only, Manufactured by Somerset Therapeutics Limited, 54/1, Boodhihal Village, Nelamangala, Bangalore - 562123, Karnataka, India, Manufactured for: Blu

  4. March 21, 2025 · Class II · Ongoing · D-0356-2025 · Haloperidol decanoate

    Lack of Assurance of Sterility: Media fill with bacterial contamination

    Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41

  5. March 21, 2025 · Class II · Ongoing · D-0357-2025 · Haloperidol decanoate

    Lack of Assurance of Sterility: Media fill with bacterial contamination

    Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: BluePoint Laboratories NDC 68001-581-41 (individual carton) and

2024

  1. June 25, 2024 · Class I · Ongoing · D-0619-2024 · Potassium chloride

    Failed Dissolution Specifications

    Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 68001-396-03), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2,

2023

  1. January 11, 2023 · Class II · Terminated · D-0269-2023 · Metoprolol

    Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.

    Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-count bottle, NDC 68001-501-03. Manufactured by Alkem Laboratories Ltd., India. For BluePoint Laborat

2022

  1. July 22, 2022 · Class III · Terminated · D-1334-2022 · Azacitidine

    Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.

    Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56

2021

  1. December 20, 2021 · Class II · Terminated · D-0451-2022 · Metoprolol

    Failed Dissolution Specifications

    Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-03

2020

  1. July 17, 2020 · Class II · Terminated · D-1413-2020 · Lisinopril

    Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg

    Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Limited, Nagpur INDIA, For BluePoint Laboratories NDC 68001-334-08

Show the 2 older recalls

2019

  1. May 9, 2019 · Class II · Terminated · D-1467-2019 · Anastrozole

    GMP Deviations: Potential cross contamination due to cleaning procedure failure.

    Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 68001-155-08) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories

  2. February 19, 2019 · Class III · Terminated · D-1584-2019 · Lovastatin

    CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.

    Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-316-00) and b)1000-count bottles (NDC 68001-316-08), Rx Only, Manufactured by: Lupin Limited, Goa 403 722 INDIA For BluePoint Laboratories.

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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