Apotex recalls 20mg Aripiprazole tablets due to failed dissolution testing at 12 months. This may affect medication effectiveness. Check NDC codes for affected batches.
Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
Apotex is recalling 20mg Aripiprazole tablets that failed dissolution testing at the 12-month stability point. This could mean the medication doesn't work as intended, so affected users should contact their doctor.
The tablets failed dissolution testing at the 12-month stability point, meaning they may not release the active ingredient properly in the body. This could lead to reduced effectiveness of the medication over time.
People who have the 1,000-count or 30-count bottles of Apotex Aripiprazole 20mg tablets with specific NDC and UPC numbers. Those taking this medication for mental health conditions are most at risk.
Check for the 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2) or 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7) with expiration dates of 04/2023.
Talk to your healthcare provider about the recalled tablets and possible alternatives.
The tablets failed dissolution testing at the 12-month stability point, which could mean they don't work as intended.
Look for the 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2) or 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7) with expiration dates of 04/2023.
No, but you should contact your doctor to discuss alternatives since the medication may not work as intended.
We’ve drafted a message you can send Apotex to request your refund or repair — edit it as you like.
Subject: Recall D-1285-2022 — Apotex Apotex Hello, I own a Apotex that is covered by recall D-1285-2022 from Apotex. 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.
