Harvard Drug Group Recalls Aripiprazole Tablets Due to Assay Issues
The Harvard Drug Group is recalling Aripiprazole Tablets, 2 mg due to out-of-specification assay results. Check your lot number and expiration date.
Use caution until it’s fixed
Superpotent Drug; out of specification results for assay (manufacturer)
Contact the company
What happened, in plain English
The Harvard Drug Group is recalling Aripiprazole Tablets, 2 mg, 30 count unit dose boxes because the drug's assay is out of specification. This means the amount of active ingredient may not match what is listed on the label. The product was distributed nationwide and in Puerto Rico. Read more at govinfonow.com/recall/42106-harvard-drug-group-recalls-aripiprazole-tablets-due-to-assay-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/42106-harvard-drug-group-recalls-aripiprazole-tablets-due-to-assay-issues · Updated October 11, 2026 · FDA enforcement record: FDA #D-0692-2017
Cite this page
“Harvard Drug Group Recalls Aripiprazole Tablets Due to Assay Issues.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/42106-harvard-drug-group-recalls-aripiprazole-tablets-due-to-assay-issues. Based on FDA recall #D-0692-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0692-2017%22&limit=1).
Why it’s dangerous
The hazard is that the assay (the measurement of the drug's strength) is out of specification. This could result in patients receiving a dose that is either too weak or too strong, potentially affecting the treatment's effectiveness or safety profile.
Who’s affected
Patients who have been prescribed Aripiprazole Tablets, 2 mg from this specific lot are affected. Individuals taking this medication should verify their supply against the recall details to ensure they do not have the impacted product.
How to tell if you have this one
Look for Aripiprazole Tablets, 2 mg in a 30 count unit dose box. The product is manufactured by Apotex Inc. and distributed by Major Pharmaceuticals. Check for NDC 0904-6509-04, Lot number T-00601, and an expiration date of 04-2017.
- Brand
The Harvard Drug Group- Category
Drug
What to do — step by step
Check Your Medication
Verify if your Aripiprazole Tablets match the recalled NDC, lot number, and expiration date listed in the record.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider to determine if you have the recalled product and what steps to take next.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and PR” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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-0692-2017 (December 27, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0692-2017 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.