Hetero Labs, Ltd. - Unit III recalls Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway,
Hetero Labs recalls 10mg Aripiprazole tablets with CGMP deviations. These tablets may not meet specifications. Stop using if you have the affected lot numbers.
Recall notice
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Contact the company & request your remedy
What happened, in plain English
Hetero Labs is recalling 10mg Aripiprazole tablets that were made with active pharmaceutical ingredients not meeting all intended specifications. This could affect safety and effectiveness of the medication. Read more at govinfonow.com/recall/40948-hetero-labs-aripiprazole-tablets-10mg-recall-cgmp-deviations-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40948-hetero-labs-aripiprazole-tablets-10mg-recall-cgmp-deviations-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0594-2018
Cite this page
“Hetero Labs Aripiprazole Tablets 10mg Recall: CGMP Deviations Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40948-hetero-labs-aripiprazole-tablets-10mg-recall-cgmp-deviations-risk. Based on FDA recall #D-0594-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0594-2018%22&limit=1).
Why it’s dangerous
The manufacturing process had issues with the active pharmaceutical ingredient, meaning the tablets may not meet the required quality standards. This could lead to inconsistent medication effects or safety concerns.
Who’s affected
People with a prescription for these tablets who received the recalled lot numbers (ARI17089 or ARI17090) from a pharmacy. Those using the medication for mental health conditions are most at risk.
How to tell if you have this one
Check your prescription bottle for the lot numbers ARI17089 or ARI17090, which expire May 2019. The product is a 10mg Aripiprazole tablet, 30-count bottle, Rx only.
- Brand
Hetero Labs- Category
Drug
What to do — step by step
Check Your Medication
Look for the lot numbers ARI17089 or ARI17090 on the bottle label.
Questions people ask
What is the recall for?
Hetero Labs is recalling 10mg Aripiprazole tablets with lot numbers ARI17089 or ARI17090 that had CGMP deviations.
How do I know if I have the recalled product?
Check the bottle for lot numbers ARI17089 or ARI17090, which expire May 2019.
What should I do if I have the recalled product?
The recall record does not specify a remedy, so contact your pharmacist or healthcare provider for advice.
Contact Hetero Labs
We’ve drafted a message you can send Hetero Labs to request your refund or repair — edit it as you like.
Subject: Recall D-0594-2018 — Hetero Labs Hetero Labs Hello, I own a Hetero Labs that is covered by recall D-0594-2018 from Hetero Labs. 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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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-0594-2018 (January 10, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0594-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.