Lower risk Drug recall · FDA · Published April 24, 2024

Aurobindo Pharma Clorazepate Tablets Recall: Discoloration Hazard

Aurobindo Pharma recalls 7.5mg Clorazepate Dipotassium Tablets with yellow spots. Discard affected lots to avoid potential discoloration issues.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0492-2024Drug Aurobindo Pharma ›

Lower-risk recall

Discoloration: Dotted and yellow spots on tablets

Take action

Contact the company

Recalling firmAurobindo Pharma USA Inc.279 Princeton Hightstown Rd · East Windsor, NJ 08520-1401

✎ GovInfoNow plain-language explainer

Aurobindo Pharma is recalling 7.5mg Clorazepate Dipotassium Tablets that show yellow spots on the tablets. This discoloration could indicate a quality issue that might affect the medication's safety. Read more at govinfonow.com/recall/32711-aurobindo-pharma-clorazepate-tablets-recall-discoloration-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/32711-aurobindo-pharma-clorazepate-tablets-recall-discoloration-hazard · Updated September 23, 2026 · FDA enforcement record: FDA #D-0492-2024

Cite this page

“Aurobindo Pharma Clorazepate Tablets Recall: Discoloration Hazard.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32711-aurobindo-pharma-clorazepate-tablets-recall-discoloration-hazard. Based on FDA recall #D-0492-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0492-2024%22&limit=1).

The FDA announced on April 24, 2024, that Aurobindo Pharma USA Inc. is recalling Clorazepate Dipotassium Tablets, USP, 7.5 mg, due to discoloration hazards. The agency stated the recall covers products distributed nationwide.

How to tell if you have it

Brand: Aurobindo Pharma
Product: Clorazepate Dipotassium Tablets, USP, 7.5 mg
NDC 13107-283-01 (100 tablets per bottle)
NDC 13107-283-05 (500 tablets per bottle)
Lot #s: CZB124001B, CZB124002B, CZB124003B, Exp. 12/31/2025
Lot #s: CZB124001A, CZB124003A, Exp. 12/31/2025

The hazard

GovInfoNow's records show the tablets may exhibit dotted and yellow spots. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Aurobindo Pharma USA Inc has 32 other recalls on record since 2013-04-09. Other recent recalls of similar products include Hetero Labs Pantoprazole Tablets Recall (2026-03-26) and Blossom Pharmaceuticals Globe Clotrimazole Cream Recall (2025-10-31).

How to tell if you have this one

Check for yellow spots or dots on the tablets. The affected products have NDC numbers 13107-283-01 (100 tablets) and 13107-283-05 (500 tablets).

Brand
Aurobindo Pharma
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide in the USA
NDC
13107-282-01, 13107-282-05, 13107-283-01, 13107-283-05, 13107-284-01

Recall number	Product, codes & lots	Quantity
D-0491-2024	Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.; Lot #s: a) CZA124001B, CZA124002B, CZA124003B, Exp. 12/31/2025; b) CZA124001A, CZA124003A, Exp. 12/31/2025.	6696 bottles
D-0492-2024	Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.; Lot #s: a) CZB124001B, CZB124002B, CZB124003B, Exp. 12/31/2025; b) CZB124001A, CZB124003A, Exp. 12/31/2025.	6909 bottles

Based on the official FDA remedy

What to do — step by step

Check for discoloration
Look for yellow spots or dots on the tablets to determine if they are affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 21 days after the firm started it.

Apr 24, 2024Firm started the recall
May 8, 2024FDA classified it Class II
May 15, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Aurobindo Pharma recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/32711-aurobindo-pharma-clorazepate-tablets-recall-discoloration-hazard">Aurobindo Pharma Clorazepate Tablets Recall: Discoloration Hazard (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0492-2024 (April 24, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0492-2024 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.