Aurobindo Pharma recalls 3.75mg Clorazepate tablets with yellow spots due to discoloration. Rx-only medication distributed in India. Check NDC numbers and expiration dates for affected lots.
Discoloration: Dotted and yellow spots on tablets
Aurobindo Pharma is recalling Clorazepate Dipotassium Tablets (3.75 mg) that show yellow spots or dots on the tablets. This discoloration could indicate a quality issue that might affect the medication's safety or effectiveness.
Discoloration on the tablets (yellow spots or dots) may indicate a manufacturing defect that could affect the medication's safety or effectiveness. This is a quality issue that might not cause immediate harm but could lead to improper dosing or reduced potency.
Prescription medication users who have the specific bottle sizes (100 or 500 tablets) with the listed NDC numbers and expiration dates. People taking this medication for anxiety or seizures are most at risk.
Check for yellow spots or dots on the tablets. Affected products have NDC numbers 13107-282-01 (100 tablets) or 13107-282-05 (500 tablets), manufactured in India with expiration dates of 12/31/2025.
Look for yellow spots or dots on the tablets to determine if they are affected.
The recall is due to discoloration (yellow spots or dots) on the tablets, which may indicate a quality issue affecting safety or effectiveness.
Affected products are 3.75 mg Clorazepate Dipotassium Tablets with NDC 13107-282-01 (100 tablets) or NDC 13107-282-05 (500 tablets), manufactured in India with expiration dates of 12/31/2025.
No action is required beyond checking for discoloration. The recall does not require stopping use immediately.
We’ve drafted a message you can send Aurobindo Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0491-2024 — Aurobindo Pharma Aurobindo Pharma Hello, I own a Aurobindo Pharma that is covered by recall D-0491-2024 from Aurobindo Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
