Medications & Supplements/Prescription Drugs

Clorazepate Dipotassium Tablets Recalled for Dotted and Yellow Spots

Agency Publication Date: May 8, 2024

Summary

Aurobindo Pharma USA Inc. is recalling 13,605 bottles of Clorazepate Dipotassium Tablets (3.75 mg and 7.5 mg strengths) due to reports of discoloration, specifically dotted and yellow spots on the tablets. Clorazepate Dipotassium is a prescription medication used to treat anxiety, seizures, and symptoms of alcohol withdrawal. The recall affects 100-count and 500-count bottles distributed nationwide in the United States.

Risk

The tablets exhibit abnormal physical discoloration which indicates a quality defect. While no incidents of patient harm have been reported, consumers should not ingest tablets with visible spots or discoloration as it may affect the medication's performance.

What You Should Do

This recall affects Clorazepate Dipotassium Tablets (3.75 mg and 7.5 mg) sold in 100-count and 500-count bottles with NDC codes 13107-282-01, 13107-282-05, 13107-283-01, and 13107-283-05.
Identify your medication by checking the lot number and expiration date on the bottle label. Affected lots start with prefixes CZA or CZB and have an expiration date of 12/31/2025. 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 Aurobindo Pharma USA Inc. 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: Clorazepate Dipotassium Tablets, USP, 3.75 mg

Variants: 100 tablets per bottle, 500 tablets per bottle

Lot Numbers:

CZA124001B (Exp. 12/31/2025)

CZA124002B (Exp. 12/31/2025)

CZA124003B (Exp. 12/31/2025)

CZA124001A (Exp. 12/31/2025)

CZA124003A (Exp. 12/31/2025)

NDC:

13107-282-01

13107-282-05

Distributed by Aurobindo Pharma USA, Inc.; Made in India.

Product: Clorazepate Dipotassium Tablets, USP, 7.5 mg

Variants: 100 tablets per bottle, 500 tablets per bottle

Lot Numbers:

CZB124001B (Exp. 12/31/2025)

CZB124002B (Exp. 12/31/2025)

CZB124003B (Exp. 12/31/2025)

CZB124001A (Exp. 12/31/2025)

CZB124003A (Exp. 12/31/2025)

NDC:

13107-283-01

13107-283-05

Distributed by Aurobindo Pharma USA, Inc.; Made in India.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94500

Status: Active

Manufacturer: Aurobindo Pharma USA Inc.

Sold By: Retail pharmacies

Manufactured In: India, United States

Units Affected: 2 products (6696 bottles; 6909 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 affects Clorazepate Dipotassium Tablets (3.75 mg and 7.5 mg) sold in 100-count and 500-count bottles with NDC codes 13107-282-01, 13107-282-05, 13107-283-01, and 13107-283-05.

Identify your medication by checking the lot number and expiration date on the bottle label. Affected lots start with prefixes CZA or CZB and have an expiration date of 12/31/2025. 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 Aurobindo Pharma USA Inc. 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: Clorazepate Dipotassium Tablets, USP, 3.75 mg

Variants: 100 tablets per bottle, 500 tablets per bottle

Lot Numbers:

CZA124001B (Exp. 12/31/2025)

CZA124002B (Exp. 12/31/2025)

CZA124003B (Exp. 12/31/2025)

CZA124001A (Exp. 12/31/2025)

CZA124003A (Exp. 12/31/2025)

NDC:

13107-282-01

13107-282-05

Distributed by Aurobindo Pharma USA, Inc.; Made in India.

Product: Clorazepate Dipotassium Tablets, USP, 7.5 mg

Variants: 100 tablets per bottle, 500 tablets per bottle

Lot Numbers:

CZB124001B (Exp. 12/31/2025)

CZB124002B (Exp. 12/31/2025)

CZB124003B (Exp. 12/31/2025)

CZB124001A (Exp. 12/31/2025)

CZB124003A (Exp. 12/31/2025)

NDC:

13107-283-01

13107-283-05

Distributed by Aurobindo Pharma USA, Inc.; Made in India.