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Barr Laboratories Llc

United States See location details
Last FDA Action: May 9, 2025

This drug manufacturing facility is registered with the FDA by Barr Laboratories Llc. ProPublica was able to identify at least 152 generic drugs that have been manufactured at this facility.

Facility Inspection History

The FDA is responsible for inspecting drug manufacturing facilities for violations of good manufacturing practices, such as a lack of documented drug quality testing or contaminated equipment. Below is a timeline of FDA inspections and outcomes for this facility assembled by ProPublica.

Note: ProPublica does not provide medical advice. Stopping your medication, doctors warn, can be dangerous. Please consult your doctor first if you have concerns. Read more
13 Known Inspections

The inspections we were able to locate using available FDA data do not include inspections in advance of the release of a new drug product.

11 Inspections Found Issues

When issues are observed, inspectors usually file an FDA 483 form with citations. In more serious cases, the FDA can issue warning letters or even ban the import of drugs from the facility.

  • May 9, 2025
    May 9, 2025
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    3 citations
    Approval and review of procedures
    Written procedures are not reviewed and approved by the quality control unit.
    Lab controls established, including changes
    The establishment of specifications and test procedures including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
    Review of representative number of batches
    Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Nov 4, 2022
    Nov 4, 2022
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Nov 9, 2018
    Nov 9, 2018
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    1 citation
    Calibration/Inspection/Checking not done
    Routine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Jun 8, 2018
    Jun 8, 2018
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Feb 28, 2018
    Feb 28, 2018
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Apr 14, 2017
    Apr 14, 2017
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Dec 18, 2015
    Dec 18, 2015
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Jul 14, 2015
    Jul 14, 2015
    Inspection

    The FDA determined this facility was in an acceptable state.

    This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors.
  • Aug 23, 2013
    Aug 23, 2013
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Jan 18, 2013
    Jan 18, 2013
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Jul 26, 2012
    Jul 26, 2012
    Inspection

    The FDA determined this facility was in an acceptable state.

    This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors.
  • Aug 25, 2011
    Aug 25, 2011
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Apr 8, 2010
    Apr 8, 2010
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.

Drugs Manufactured Here

Below is a list of generic prescription drugs that we’ve been able to connect to this facility. Brand name and over-the-counter drugs, as well as labels we were unable to trace, are not included here.

Acitretin

CompanyTeva Pharmaceuticals Usa
Dosage
25mg
Light green, yellow capsule marked with TEVA 1136
NDC: 0093-1136-56

Acitretin

CompanyTeva Pharmaceuticals Usa
Dosage
10mg
Light green, white capsule marked with TEVA 1135
NDC: 0093-1135-56

Adderall

CompanyTeva Pharmaceuticals Usa
Dosage
15mg
Orange (peach) oval tablet marked with 15 d p
NDC: 57844-115-01

Adderall

CompanyTeva Pharmaceuticals Usa
Dosage
20mg
Orange (peach) round tablet marked with 2 0 dp
NDC: 57844-120-01

Adderall

CompanyTeva Pharmaceuticals Usa
Dosage
30mg
Orange (peach) round tablet marked with 3 0 dp
NDC: 57844-130-01

Adderall

CompanyTeva Pharmaceuticals Usa
Dosage
5mg
White to off-white round tablet marked with 5 dp
NDC: 57844-105-01

Adderall

CompanyTeva Pharmaceuticals Usa
Dosage
7.5mg
Blue oval tablet marked with 7 5 d p
NDC: 57844-117-01

Adderall

CompanyTeva Pharmaceuticals Usa
Dosage
10mg
Blue round tablet marked with 1 0 dp
NDC: 57844-110-01

Adderall

CompanyTeva Pharmaceuticals Usa
Dosage
12.5mg
Orange (peach) round tablet marked with 12 5 d p
NDC: 57844-112-01

Amiloride Hydrochloride And Hydrochlorothiazide

CompanyTeva Pharmaceuticals Usa
Dosage
Amiloride Hydrochloride
5mg
Hydrochlorothiazide
50mg
Light yellow round tablet marked with 555 483 barr
NDC: 0555-0483-X

Chlordiazepoxide Hydrochloride

CompanyNucare Pharmaceuticals
Dosage
25mg
Aqua green, white capsule marked with barr 159
NDC: 68071-5171-3

Chlordiazepoxide Hydrochloride

CompanyRemedyrepack
Dosage
25mg
Aqua green, white capsule marked with barr 159
NDC: 70518-0015-X

Frequently Asked Questions

What Do the Inspection Outcomes Mean?
These are the possible FDA compliance outcomes we highlight:
  • Import alert. This is rare and means drugs from this facility were banned from coming into the U.S. Specifically we are including alerts relating to FDA manufacturing standards for drug products. The agency sometimes exempts certain drugs from import bans, ostensibly to prevent drug shortages.
  • Warning letter. This is a disciplinary tool the FDA uses to lay out significant violations of federal requirements. The company has an opportunity to respond and/or provide its plans to correct the issues. The agency might later issue a “close-out letter” to say it has confirmed that issues raised in a previous warning letter were fixed. But that doesn’t always happen.
  • Unacceptable state of compliance. This means inspectors found serious issues at the facility and the agency ultimately recommended official compliance action. In cases like this, the FDA typically pauses the facility’s pending drug approvals. The agency classifies this as “official action indicated.”
  • Some issues found, but no further FDA action. This is very common. It means the FDA found issues but determined the facility can correct them voluntarily. In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time. The agency classifies this as “voluntary action indicated.”
  • Inspector documented issues. Inspectors can file notes summarizing deficiencies observed during an inspection using a 483 form. In some cases, we’re unable to connect a Form 483 to an FDA inspection designation, but we show that an inspector filed this form, perhaps as part of an inspection that was not included in the public inspection dashboard.
  • Acceptable state. This is common and the best possible outcome for an inspection. This means the FDA took no compliance action and ProPublica found no issues documented by inspectors. That doesn’t always mean no issues turned up. Sometimes, inspectors address concerns with management on site that they believe do not need to be documented on a 483. The agency classifies this as “no action indicated.”
There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.

How Did ProPublica Connect This Information?
We have written an in-depth methodology, but in short, we connected several FDA databases:
  • The Structured Product Labeling database.
  • The National Drug Code Directory.
  • The Electronic Drug Registration and Listing System.
  • Data from the agency’s inspection dashboard.
  • A spreadsheet of facility addresses we sued the FDA for, which connected them to drug application numbers.
  • Form 483 documents we received from a Freedom of Information Act Request.
ProPublica described the app and the methodology used to build it to the FDA, which did not comment. The agency previously told ProPublica that it doesn’t reveal where drugs are made on inspection reports to protect what it deemed confidential commercial information.

How Do I Report Incorrect Information?
If you work for a manufacturer or otherwise see that information we are displaying may be incorrect, please email [email protected].