Accord Healthcare recalls Doxazosin 1mg tablets due to FDA inspection finding manufacturing deviations. Products sold with NDC 16729-211-01 or 16729-211-17 may be affected. Consumers should contact the manufacturer for details.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling Doxazosin 1mg tablets after an FDA inspection found manufacturing deviations. This recall affects specific packaging with NDC numbers 16729-211-01 and 16729-211-17. The issue requires consumers to stop using these products to ensure safety.
The FDA identified manufacturing deviations during an inspection. This means the tablets may not meet quality standards, but the recall does not specify a direct risk of injury or harm in normal use.
People who have the recalled Doxazosin 1mg tablets with NDC numbers 16729-211-01 or 16729-211-17 are affected. Prescription patients using these specific products are most at risk.
Check for the NDC number 16729-211-01 on a 100-count bottle or 16729-211-17 on a 1,000-count bottle. The products were manufactured by Intas Pharmaceuticals in India and distributed by Accord Healthcare.
Look for the NDC numbers 16729-211-01 or 16729-211-17 on the packaging to confirm if the product is recalled.
The FDA found manufacturing deviations during an inspection, which means the product may not meet quality standards.
Contact Accord Healthcare directly for instructions on what to do with the recalled product.
The recall does not specify a direct risk of injury or harm in normal use, so the risk is considered low.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0386-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0386-2023 from Accord Healthcare. 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.