Apotex Aripiprazole 20mg Tablets Recall: Failed Dissolution Testing
Apotex recalls 20mg Aripiprazole tablets due to failed dissolution testing at 12 months. This may affect medication effectiveness. Check NDC codes for affected batches.
Lower-risk recall
Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/34437-apotex-aripiprazole-20mg-tablets-recall-failed-dissolution-testing.
Source Summary by GovInfoNow · govinfonow.com/recall/34437-apotex-aripiprazole-20mg-tablets-recall-failed-dissolution-testing · Updated August 18, 2026 · FDA enforcement record: FDA #D-1285-2022
Cite this page
“Apotex Aripiprazole 20mg Tablets Recall: Failed Dissolution Testing.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34437-apotex-aripiprazole-20mg-tablets-recall-failed-dissolution-testing. Based on FDA recall #D-1285-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1285-2022%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Apotex- Product
Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count- Category
Drug
What to do — step by step
Contact Your Doctor
Talk to your healthcare provider about the recalled tablets and possible alternatives.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 3.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #D-1285-2022 (July 7, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1285-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.