Accord Healthcare recalls 20 mg Tadalafil Tablets (Rx Only) manufactured in India with FDA inspection deviations. Products sold in specific packaging and batch numbers from 2022-2025. Consumers should check labels for NDC/UPC codes and batch dates.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling 20 mg Tadalafil Tablets (Rx Only) due to FDA inspection findings showing manufacturing deviations. This recall affects specific packaging and batch numbers produced between 2022 and 2025. The issue requires consumers to check their product labels for the NDC/UPC codes and batch dates to determine if they are affected.
The recall is based on FDA inspections finding manufacturing deviations in the production process. This means the medication may not meet quality standards, but the specific risks to health are not detailed in the recall notice. The FDA requires these products to be removed from circulation due to potential quality issues.
Prescription users of Tadalafil Tablets (20 mg) who purchased the recalled products from 2022-2025. Individuals with a prescription for this medication are most at risk.
Check the product label for a 30-count bottle with NDC 16729-372-10 or UPC 3 16729 37210 7, or a 500-count bottle with NDC 16729-372-16 or UPC 3 16729 37216 9. Also look for batch numbers listed in the product description, which range from P2002461 to P2202085 with expiration dates from April 2023 to March 2025.
Look for the NDC code (16729-372-10 or 16729-372-16) and UPC code (3 16729 37210 7 or 3 16729 37216 9) on the packaging.
Check the batch number on the label, which ranges from P2002461 to P2202085 with expiration dates from April 2023 to March 2025.
The FDA found manufacturing deviations during an inspection, which means the product may not meet quality standards. Accord Healthcare is recalling it to ensure safety.
Check the product label for NDC codes 16729-372-10 (30-count bottle) or 16729-372-16 (500-count bottle), and batch numbers from P2002461 to P2202085 with specific expiration dates.
The recall does not specify a stop-use instruction, so you can continue using it if you have a prescription and it's not expired. However, you should check the product details to confirm if it's part of the recall.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0417-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0417-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
