Accord Healthcare recalls 30mg Aripiprazole Tablets (NDC 16729-283-10 and 16729-283-01) after FDA inspection found manufacturing deviations. Consumers should check product labels for batch numbers and expiration dates.
CGMP Deviations: recalling drug products following an FDA inspection.
Accord Healthcare is recalling 30mg and 100-count Aripiprazole Tablets due to FDA inspection finding manufacturing deviations. This recall affects prescription medication safety as the drugs may not meet quality standards.
The FDA identified manufacturing deviations during an inspection, meaning the drug may not meet quality standards. This could affect the medication's safety and effectiveness, but the specific risk to users is not detailed in the recall notice.
Prescription medication users who have the recalled Aripiprazole Tablets (30-count or 100-count bottles) are affected. Patients taking this medication for mental health conditions are most at risk.
Check the product label for the NDC code 16729-283-10 (30-count) or 16729-283-01 (100-count). The expiration dates for these batches range from February 2023 to May 2025.
Look for the NDC code 16729-283-10 on 30-count bottles or 16729-283-01 on 100-count bottles.
The FDA found manufacturing deviations during an inspection, which means the drug may not meet quality standards.
Check the product label for the NDC code and expiration date. If you have the recalled product, contact your healthcare provider for guidance.
The recall notice does not specify the exact risks, only that manufacturing deviations were found.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0370-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0370-2023 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.