Medications & Supplements/Prescription Drugs

Alprazolam and Clobazam Tablets Recalled for Potential Cross-Contamination

Agency Publication Date: April 24, 2023

Summary

Breckenridge Pharmaceutical, Inc. is recalling various lots of Alprazolam (alprazolam) and Clobazam (clobazam) tablets due to potential cross-contamination issues during the manufacturing process in India. No illnesses or injuries have been reported to date regarding this recall. These prescription medications were distributed nationwide to pharmacies and are being recalled as a precautionary measure to ensure patient safety.

Risk

Deviations in manufacturing standards may have caused these medications to be contaminated with other substances. This poses a potential health risk as contamination could lead to unexpected side effects or impact how well the medication works for the patient.

What You Should Do

This recall affects various strengths and bottle sizes of Alprazolam (alprazolam) and Clobazam (clobazam) tablets distributed by Breckenridge Pharmaceutical, Inc.
Check your prescription bottle label for the product name, strength (ranging from 0.25mg to 2mg for Alprazolam and 10mg to 20mg for Clobazam), and NDC codes.
Identify your specific lot number and expiration date on the side or bottom of the pill bottle. 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.

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, 0.25mg, CIV

Variants: 0.25mg, Tablet, 100-count bottle, 500-count bottle, 1,000-count bottle

Lot Numbers:

5210734 (Exp 4/30/2023)

5211451 (Exp 8/31/2024)

5220529 (Exp 4/30/2025)

5210735 (Exp 4/30/2023)

5210736 (Exp 4/30/2023)

5210993 (Exp 5/31/2023)

5210994 (Exp 5/31/2023)

5211100 (Exp 6/30/2023)

5211452 (Exp 8/31/2024)

5211453 (Exp 8/31/2024)

5211454 (Exp 8/31/2024)

5211640 (Exp 10/31/2024)

5211641 (Exp 10/31/2024)

5210737 (Exp 4/30/2023)

5210995 (Exp 5/31/2023)

5211101 (Exp 6/30/2023)

5211269 (Exp 7/31/2024)

5211270 (Exp 7/31/2024)

5211271 (Exp 7/31/2024)

NDC:

51991-0704-01

Product: Alprazolam Tablets, USP, 0.5mg, CIV

Variants: 0.5mg, Tablet, 100-count bottle, 500-count bottle, 1,000-count bottle

Lot Numbers:

5210673 (Exp 3/31/2023)

5210901 (Exp 5/31/2023)

5211461 (Exp 9/30/2024)

5220291 (Exp 2/28/2025)

5220559 (Exp 5/31/2025)

5210650 (Exp 3/31/2023)

5210651 (Exp 3/31/2023)

5210652 (Exp 3/31/2023)

5210653 (Exp 3/31/2023)

5210674 (Exp 3/31/2023)

5210732 (Exp 3/31/2023)

5210733 (Exp 4/30/2023)

5210753 (Exp 4/30/2023)

5210902 (Exp 5/31/2023)

5210903 (Exp 5/31/2023)

5210904 (Exp 5/31/2023)

5211231 (Exp 7/31/2023)

5211281 (Exp 7/31/2024)

5211282 (Exp 7/31/2024)

5211283 (Exp 7/31/2024)

5211284 (Exp 7/31/2024)

5211336 (Exp 7/31/2024)

5211337 (Exp 8/31/2024)

5211338 (Exp 8/31/2024)

5211462 (Exp 9/30/2024)

5211463 (Exp 9/30/2024)

5211464 (Exp 9/30/2024)

5211465 (Exp 9/30/2024)

5211516 (Exp 9/30/2024)

5211644 (Exp 10/31/2024)

5211645 (Exp 10/31/2024)

5211690 (Exp 10/31/2024)

5210675 (Exp 3/31/2023)

5210777 (Exp 4/30/2023)

5210778 (Exp 4/30/2023)

5210996 (Exp 5/31/2023)

5211077 (Exp 6/30/2023)

5211078 (Exp 6/30/2023)

5211079 (Exp 6/30/2023)

5211080 (Exp 6/30/2023)

5211364 (Exp 8/31/2024)

5211365 (Exp 8/31/2024)

5211367 (Exp 8/31/2024)

5211366 (Exp 8/31/2024)

5211575 (Exp 10/31/2024)

5211576 (Exp 10/31/2024)

5211694 (Exp 11/30/2024)

5220066 (Exp 12/31/2024)

NDC:

51991-0705-01

51991-0705-05

51991-0705-10

Product: Alprazolam Tablets, USP, 1 mg, CIV

Variants: 1mg, Tablet, 100-count bottle, 500-count bottle, 1,000-count bottle

Lot Numbers:

5210645 (Exp 3/31/2023)

5210646 (Exp 3/31/2023)

5210647 (Exp 3/31/2023)

5210648 (Exp 3/31/2023)

5210649 (Exp 3/31/2023)

5210831 (Exp 4/30/2023)

5210832 (Exp 4/30/2023)

5210833 (Exp 4/30/2023)

5210834 (Exp 4/30/2023)

5210835 (Exp 4/30/2023)

5210905 (Exp 5/31/2023)

5210906 (Exp 5/31/2023)

5210907 (Exp 5/31/2023)

5210908 (Exp 5/31/2023)

5210909 (Exp 5/31/2023)

5210965 (Exp 5/31/2023)

5210997 (Exp 5/31/2023)

5210998 (Exp 5/31/2023)

5211175 (Exp 6/30/2023)

5211176 (Exp 6/30/2023)

5211177 (Exp 6/30/2023)

5211178 (Exp 6/30/2023)

5211179 (Exp 6/30/2023)

5211180 (Exp 6/30/2023)

5211181 (Exp 6/30/2023)

5211205 (Exp 7/31/2023)

5211206 (Exp 7/31/2023)

5211227 (Exp 7/31/2023)

5211228 (Exp 7/31/2023)

5211229 (Exp 7/31/2023)

5211334 (Exp 8/31/2024)

5211335 (Exp 8/31/2024)

5211456 (Exp 8/31/2024)

5211457 (Exp 8/31/2024)

5211458 (Exp 8/31/2024)

5211459 (Exp 9/30/2024)

5211727 (Exp 11/30/2024)

5211730 (Exp 11/30/2024)

5220028 (Exp 12/31/2024)

5220029 (Exp 12/31/2024)

5220288 (Exp 2/28/2025)

NDC:

51991-0706-01

51991-0706-05

51991-0706-10

Product: Alprazolam Tablets, USP, 2 mg, CIV

Variants: 2mg, Tablet, 100-count bottle, 500-count bottle

Lot Numbers:

5210546 (Exp 3/31/2023)

5210547 (Exp 3/31/2023)

5210548 (Exp 3/31/2023)

5210642 (Exp 3/31/2023)

5210643 (Exp 3/31/2023)

5210644 (Exp 3/31/2023)

5210766 (Exp 4/30/2023)

5210767 (Exp 4/30/2023)

5210768 (Exp 4/30/2023)

5210999 (Exp 5/31/2023)

5211000 (Exp 5/31/2023)

5211001 (Exp 5/31/2023)

5211002 (Exp 5/31/2023)

5211003 (Exp 5/31/2023)

5211004 (Exp 6/30/2023)

5211005 (Exp 6/30/2023)

5211006 (Exp 6/30/2023)

5211055 (Exp 6/30/2023)

5211332 (Exp 7/31/2024)

5211333 (Exp 7/31/2024)

5211339 (Exp 7/31/2024)

5211340 (Exp 7/31/2024)

5211341 (Exp 7/31/2024)

5211363 (Exp 8/31/2024)

5220313 (Exp 2/28/2025)

5220314 (Exp 2/28/2025)

5220315 (Exp 2/28/2025)

NDC:

51991-0707-01

51991-0707-05

Product: Clobazam Tablets, 10 mg, CIV

Variants: 10mg, Tablet, 100-count bottle

Lot Numbers:

5210085 (Exp 12/2023)

5210248 (Exp 01/2024)

5220796 (Exp 07/2025)

NDC:

51991-900-01

Product: Clobazam Tablets, 20 mg, CIV

Variants: 20mg, Tablet, 100-count bottle

Lot Numbers:

5210147 (Exp 12/2023)

NDC:

51991-901-01

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91786

Status: Resolved

Manufacturer: Breckenridge Pharmaceutical, Inc

Sold By: Pharmacies nationwide

Manufactured In: India

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 affects various strengths and bottle sizes of Alprazolam (alprazolam) and Clobazam (clobazam) tablets distributed by Breckenridge Pharmaceutical, Inc.

Check your prescription bottle label for the product name, strength (ranging from 0.25mg to 2mg for Alprazolam and 10mg to 20mg for Clobazam), and NDC codes.

Identify your specific lot number and expiration date on the side or bottom of the pill bottle. 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.

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, 0.25mg, CIV

Variants: 0.25mg, Tablet, 100-count bottle, 500-count bottle, 1,000-count bottle

Lot Numbers:

5210734 (Exp 4/30/2023)

5211451 (Exp 8/31/2024)

5220529 (Exp 4/30/2025)

5210735 (Exp 4/30/2023)

5210736 (Exp 4/30/2023)

5210993 (Exp 5/31/2023)

5210994 (Exp 5/31/2023)

5211100 (Exp 6/30/2023)

5211452 (Exp 8/31/2024)

5211453 (Exp 8/31/2024)

5211454 (Exp 8/31/2024)

5211640 (Exp 10/31/2024)

5211641 (Exp 10/31/2024)

5210737 (Exp 4/30/2023)

5210995 (Exp 5/31/2023)

5211101 (Exp 6/30/2023)

5211269 (Exp 7/31/2024)

5211270 (Exp 7/31/2024)

5211271 (Exp 7/31/2024)

NDC:

51991-0704-01

Product: Alprazolam Tablets, USP, 0.5mg, CIV

Variants: 0.5mg, Tablet, 100-count bottle, 500-count bottle, 1,000-count bottle

Lot Numbers:

5210673 (Exp 3/31/2023)

5210901 (Exp 5/31/2023)

5211461 (Exp 9/30/2024)

5220291 (Exp 2/28/2025)

5220559 (Exp 5/31/2025)

5210650 (Exp 3/31/2023)

5210651 (Exp 3/31/2023)

5210652 (Exp 3/31/2023)

5210653 (Exp 3/31/2023)

5210674 (Exp 3/31/2023)

5210732 (Exp 3/31/2023)

5210733 (Exp 4/30/2023)

5210753 (Exp 4/30/2023)

5210902 (Exp 5/31/2023)

5210903 (Exp 5/31/2023)

5210904 (Exp 5/31/2023)

5211231 (Exp 7/31/2023)

5211281 (Exp 7/31/2024)

5211282 (Exp 7/31/2024)

5211283 (Exp 7/31/2024)

5211284 (Exp 7/31/2024)

5211336 (Exp 7/31/2024)

5211337 (Exp 8/31/2024)

5211338 (Exp 8/31/2024)

5211462 (Exp 9/30/2024)

5211463 (Exp 9/30/2024)

5211464 (Exp 9/30/2024)

5211465 (Exp 9/30/2024)

5211516 (Exp 9/30/2024)

5211644 (Exp 10/31/2024)

5211645 (Exp 10/31/2024)

5211690 (Exp 10/31/2024)

5210675 (Exp 3/31/2023)

5210777 (Exp 4/30/2023)

5210778 (Exp 4/30/2023)

5210996 (Exp 5/31/2023)

5211077 (Exp 6/30/2023)

5211078 (Exp 6/30/2023)

5211079 (Exp 6/30/2023)

5211080 (Exp 6/30/2023)

5211364 (Exp 8/31/2024)

5211365 (Exp 8/31/2024)

5211367 (Exp 8/31/2024)

5211366 (Exp 8/31/2024)

5211575 (Exp 10/31/2024)

5211576 (Exp 10/31/2024)

5211694 (Exp 11/30/2024)

5220066 (Exp 12/31/2024)

NDC:

51991-0705-01

51991-0705-05

51991-0705-10

Product: Alprazolam Tablets, USP, 1 mg, CIV

Variants: 1mg, Tablet, 100-count bottle, 500-count bottle, 1,000-count bottle

Lot Numbers:

5210645 (Exp 3/31/2023)

5210646 (Exp 3/31/2023)

5210647 (Exp 3/31/2023)

5210648 (Exp 3/31/2023)

5210649 (Exp 3/31/2023)

5210831 (Exp 4/30/2023)

5210832 (Exp 4/30/2023)

5210833 (Exp 4/30/2023)

5210834 (Exp 4/30/2023)

5210835 (Exp 4/30/2023)

5210905 (Exp 5/31/2023)

5210906 (Exp 5/31/2023)

5210907 (Exp 5/31/2023)

5210908 (Exp 5/31/2023)

5210909 (Exp 5/31/2023)

5210965 (Exp 5/31/2023)

5210997 (Exp 5/31/2023)

5210998 (Exp 5/31/2023)

5211175 (Exp 6/30/2023)

5211176 (Exp 6/30/2023)

5211177 (Exp 6/30/2023)

5211178 (Exp 6/30/2023)

5211179 (Exp 6/30/2023)

5211180 (Exp 6/30/2023)

5211181 (Exp 6/30/2023)

5211205 (Exp 7/31/2023)

5211206 (Exp 7/31/2023)

5211227 (Exp 7/31/2023)

5211228 (Exp 7/31/2023)

5211229 (Exp 7/31/2023)

5211334 (Exp 8/31/2024)

5211335 (Exp 8/31/2024)

5211456 (Exp 8/31/2024)

5211457 (Exp 8/31/2024)

5211458 (Exp 8/31/2024)

5211459 (Exp 9/30/2024)

5211727 (Exp 11/30/2024)

5211730 (Exp 11/30/2024)

5220028 (Exp 12/31/2024)

5220029 (Exp 12/31/2024)

5220288 (Exp 2/28/2025)

NDC:

51991-0706-01

51991-0706-05

51991-0706-10

Product: Alprazolam Tablets, USP, 2 mg, CIV

Variants: 2mg, Tablet, 100-count bottle, 500-count bottle

Lot Numbers:

5210546 (Exp 3/31/2023)

5210547 (Exp 3/31/2023)

5210548 (Exp 3/31/2023)

5210642 (Exp 3/31/2023)

5210643 (Exp 3/31/2023)

5210644 (Exp 3/31/2023)

5210766 (Exp 4/30/2023)

5210767 (Exp 4/30/2023)

5210768 (Exp 4/30/2023)

5210999 (Exp 5/31/2023)

5211000 (Exp 5/31/2023)

5211001 (Exp 5/31/2023)

5211002 (Exp 5/31/2023)

5211003 (Exp 5/31/2023)

5211004 (Exp 6/30/2023)

5211005 (Exp 6/30/2023)

5211006 (Exp 6/30/2023)

5211055 (Exp 6/30/2023)

5211332 (Exp 7/31/2024)

5211333 (Exp 7/31/2024)

5211339 (Exp 7/31/2024)

5211340 (Exp 7/31/2024)

5211341 (Exp 7/31/2024)

5211363 (Exp 8/31/2024)

5220313 (Exp 2/28/2025)

5220314 (Exp 2/28/2025)

5220315 (Exp 2/28/2025)

NDC:

51991-0707-01

51991-0707-05

Product: Clobazam Tablets, 10 mg, CIV

Variants: 10mg, Tablet, 100-count bottle

Lot Numbers:

5210085 (Exp 12/2023)

5210248 (Exp 01/2024)

5220796 (Exp 07/2025)

NDC:

51991-900-01

Product: Clobazam Tablets, 20 mg, CIV

Variants: 20mg, Tablet, 100-count bottle

Lot Numbers:

5210147 (Exp 12/2023)

NDC:

51991-901-01