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Drug company (FDA labeler)

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901)

NDC labeler code: 23155

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
6Products (NDC)
1FDA applications
21Recalls

Prescription medicines

FDA applications for these products

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
ApprovedApplicationMedicineSponsor
September 30, 2002ANDA076102 Lisinopril
LISINOPRIL		Heritage

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

Recall timeline

2026

  1. July 30, 2026 · Class II · Ongoing · D-0768-2026 · Clindamycin palmitate hydrochloride

    Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.

    CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51

  2. June 7, 2026 · Class II · Ongoing · D-0662-2026 · Methohexital sodium

    Failed Impurities/Degradation Specifications

    Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ

2025

  1. October 6, 2025 · Class II · Ongoing · D-0109-2026 · Desipramine hydrochloride

    CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

    Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

  2. October 6, 2025 · Class II · Ongoing · D-0110-2026 · Desipramine hydrochloride

    CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

    Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

  3. October 6, 2025 · Class II · Ongoing · D-0108-2026 · Desipramine hydrochloride

    CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

    Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

  4. October 6, 2025 · Class II · Ongoing · D-0111-2026 · Desipramine hydrochloride

    CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

    Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

  5. October 6, 2025 · Class II · Ongoing · D-0112-2026 · Desipramine hydrochloride

    CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

    Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

  6. October 6, 2025 · Class II · Ongoing · D-0107-2026 · Desipramine hydrochloride

    CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

    Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.

2022

  1. November 23, 2022 · Class II · Terminated · D-0072-2023 · Desmopressin acetate

    Subpotent Drug

    Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816, NDC 23155-490-01

2021

  1. April 21, 2021 · Class III · Terminated · D-0367-2021 · Acyclovir

    Labeling: Incorrect or Missing Lot and/or Exp Date

    Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-227-01. Packaged in 150 cc white HDPE bottle

  2. March 15, 2021 · Class II · Terminated · D-0491-2021 · Calcium acetate

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    Calcium Acetate Capsules 667 mg 200 Capsules Rx only NDC 23155-531-02 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724

  3. March 15, 2021 · Class II · Terminated · D-0489-2021 · Bupropion

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724

  4. March 15, 2021 · Class II · Terminated · D-0490-2021 · Acetazolamide

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724

2020

  1. October 23, 2020 · Class III · Terminated · D-0108-2021 · Felodipine

    Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A

    Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 Made in India, NDC 23155-050-01

  2. March 23, 2020 · Class I · Terminated · D-1255-2020 · Tetracycline hydrochloride

    Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.

    Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-017-01

  3. March 23, 2020 · Class I · Terminated · D-1254-2020 · Tetracycline hydrochloride

    Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.

    Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-018-01

2019

  1. May 21, 2019 · Class I · Terminated · D-1397-2019 · Prochlorperazine

    Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .

    PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India. Mfg for: Heritage Pharmaceuticals Inc. NDC 23155-294-31

  2. May 21, 2019 · Class I · Terminated · D-1398-2019 · Amikacin

    Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .

    AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mfd. by: Emcure Pharmaceuticals, Ltd., Hinjawadi, Pune, India Mfd. for: Heritage Pharmaceuticals Inc.. NDC 23155-290-32

2018

  1. October 15, 2018 · Class II · Terminated · D-0094-2019 · Cidofovir dihydrate

    Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle

    Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India, Mfg for: Heritage Pharmaceuticals Inc. UPC 323155216388, NDC 23155-216-31

2015

  1. March 25, 2015 · Class II · Terminated · D-0436-2015 · Glipizide and metformin hydrochloride

    Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.

    GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724, NDC: 23155-116-01.

  2. February 25, 2015 · Class II · Terminated · D-0415-2015 · Colistimethate sodium

    Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.

    Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc. NDC 23155-193-31

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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