Medications & Supplements/Prescription Drugs

Par Pharmaceutical Alprazolam and Pyrazinamide Recalled for Manufacturing Issues

Agency Publication Date: February 17, 2022

Summary

ANI Pharmaceuticals, Inc. has voluntarily recalled 529,346 bottles of various Alprazolam tablets (generic Xanax) and Pyrazinamide tablets distributed by Par Pharmaceutical. The recall is due to manufacturing deviations, which means the drugs were not produced in accordance with strict quality and safety standards. There have been no reports of injuries or illnesses related to these products to date.

Risk

Manufacturing deviations can result in medication that does not meet established standards for purity, strength, or safety. While no injuries have been reported, using medication that fails to meet these quality controls could lead to ineffective treatment or unexpected side effects.

What You Should Do

This recall involves Alprazolam tablets (0.25 mg, 0.5 mg, 1.0 mg, and 2.0 mg strengths) and Pyrazinamide tablets (500 mg) distributed by Par Pharmaceutical and packaged in 100-count, 500-count, and 1000-count bottles.
Check your medication bottles for National Drug Codes (NDCs) including 67253-900-10, 67253-901-11, 67253-902-50, 67253-903-10, and 67253-660-10. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Alprazolam Tablets, USP 0.25 mg

Variants: 100-count bottle, 500-count bottle, 1000-count bottle

Lot Numbers:

19C003A (Exp 03/2022)

19G002A (Exp 07/2022)

19C004B (Exp 03/2022)

19C048C (Exp 03/2022)

NDC:

67253-900-10

67253-900-50

67253-900-11

Distributed by Par Pharmaceutical Chestnut Ridge, NY.

Product: Alprazolam Tablets, USP 0.5 mg

Variants: 100-count bottle, 500-count bottle, 1000-count bottle

Lot Numbers:

19B029A (Exp 02/2022)

19D021A (Exp 04/2022)

19A087B (Exp 02/2022)

19A088B (Exp 02/2022)

19A089B (Exp 02/2022)

19A090B (Exp 02/2022)

19A086B (Exp 02/2022)

19A091B (Exp 02/2022)

19B019B (Exp 02/2022)

19B020C (Exp 02/2022)

19B021C (Exp 02/2022)

19B027C (Exp 02/2022)

19B028C (Exp 02/2022)

19E056C (Exp 05/2022)

19E057C (Exp 05/2022)

19E059C (Exp 06/2022)

19G072C (Exp 07/2022)

NDC:

67253-901-10

67253-901-50

67253-901-11

Distributed by Par Pharmaceutical Chestnut Ridge, NY.

Product: Alprazolam Tablets, USP 1.0 mg

Variants: 100-count bottle, 500-count bottle, 1000-count bottle

Lot Numbers:

19B081A (Exp 02/2022)

19E088A (Exp 05/2022)

19E089A (Exp 05/2022)

19A102B (Exp 02/2022)

19D067B (Exp 04/2022)

19D068B (Exp 04/2022)

19D070C (Exp 05/2022)

19F045C (Exp 06/2022)

19F046C (Exp 06/2022)

19B082C (Exp 03/2022)

19B083C (Exp 03/2022)

19D069C (Exp 05/2022)

NDC:

67253-902-10

67253-902-50

67253-902-11

Distributed by Par Pharmaceutical Chestnut Ridge, NY.

Product: Alprazolam Tablets, USP 2.0 mg

Variants: 100-count bottle, 500-count bottle

Lot Numbers:

19C002A (Exp 03/2022)

19E012A (Exp 05/2022)

19E013A (Exp 05/2022)

19C100B (Exp 04/2022)

19E001B (Exp 05/2022)

19E002B (Exp 05/2022)

NDC:

67253-903-10

67253-903-50

Distributed by Par Pharmaceutical Chestnut Ridge, NY.

Product: Pyrazinamide Tablets, USP 500 mg

Variants: 100-count bottle

Lot Numbers:

19B064A (Exp 03/2022)

NDC:

67253-660-10

Manufactured by ULTRAtab Laboratories, Inc. Highland, NY.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89556

Status: Resolved

Manufacturer: ANI Pharmaceuticals, Inc.

Sold By: Par Pharmaceutical; Pharmacies

Manufactured In: United States

Units Affected: 5 products (73,920 bottles; 205,662 bottles; 173,499 bottles; 70,788 bottles; 5,477 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves Alprazolam tablets (0.25 mg, 0.5 mg, 1.0 mg, and 2.0 mg strengths) and Pyrazinamide tablets (500 mg) distributed by Par Pharmaceutical and packaged in 100-count, 500-count, and 1000-count bottles.

Check your medication bottles for National Drug Codes (NDCs) including 67253-900-10, 67253-901-11, 67253-902-50, 67253-903-10, and 67253-660-10. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Alprazolam Tablets, USP 0.25 mg

Variants: 100-count bottle, 500-count bottle, 1000-count bottle

Lot Numbers:

19C003A (Exp 03/2022)

19G002A (Exp 07/2022)

19C004B (Exp 03/2022)

19C048C (Exp 03/2022)

NDC:

67253-900-10

67253-900-50

67253-900-11

Distributed by Par Pharmaceutical Chestnut Ridge, NY.

Product: Alprazolam Tablets, USP 0.5 mg

Variants: 100-count bottle, 500-count bottle, 1000-count bottle

Lot Numbers:

19B029A (Exp 02/2022)

19D021A (Exp 04/2022)

19A087B (Exp 02/2022)

19A088B (Exp 02/2022)

19A089B (Exp 02/2022)

19A090B (Exp 02/2022)

19A086B (Exp 02/2022)

19A091B (Exp 02/2022)

19B019B (Exp 02/2022)

19B020C (Exp 02/2022)

19B021C (Exp 02/2022)

19B027C (Exp 02/2022)

19B028C (Exp 02/2022)

19E056C (Exp 05/2022)

19E057C (Exp 05/2022)

19E059C (Exp 06/2022)

19G072C (Exp 07/2022)

NDC:

67253-901-10

67253-901-50

67253-901-11

Distributed by Par Pharmaceutical Chestnut Ridge, NY.

Product: Alprazolam Tablets, USP 1.0 mg

Variants: 100-count bottle, 500-count bottle, 1000-count bottle

Lot Numbers:

19B081A (Exp 02/2022)

19E088A (Exp 05/2022)

19E089A (Exp 05/2022)

19A102B (Exp 02/2022)

19D067B (Exp 04/2022)

19D068B (Exp 04/2022)

19D070C (Exp 05/2022)

19F045C (Exp 06/2022)

19F046C (Exp 06/2022)

19B082C (Exp 03/2022)

19B083C (Exp 03/2022)

19D069C (Exp 05/2022)

NDC:

67253-902-10

67253-902-50

67253-902-11

Distributed by Par Pharmaceutical Chestnut Ridge, NY.

Product: Alprazolam Tablets, USP 2.0 mg

Variants: 100-count bottle, 500-count bottle

Lot Numbers:

19C002A (Exp 03/2022)

19E012A (Exp 05/2022)

19E013A (Exp 05/2022)

19C100B (Exp 04/2022)

19E001B (Exp 05/2022)

19E002B (Exp 05/2022)

NDC:

67253-903-10

67253-903-50

Distributed by Par Pharmaceutical Chestnut Ridge, NY.

Product: Pyrazinamide Tablets, USP 500 mg

Variants: 100-count bottle

Lot Numbers:

19B064A (Exp 03/2022)

NDC:

67253-660-10

Manufactured by ULTRAtab Laboratories, Inc. Highland, NY.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89556

Status: Resolved

Manufacturer: ANI Pharmaceuticals, Inc.

Sold By: Par Pharmaceutical; Pharmacies

Manufactured In: United States

Units Affected: 5 products (73,920 bottles; 205,662 bottles; 173,499 bottles; 70,788 bottles; 5,477 bottles)

Distributed To: Nationwide