Harvard Drug Recalls Paliperidone 9mg Tablets for Dissolution Failure
The Harvard Drug Group is recalling Paliperidone Extended-Release Tablets, 9 mg due to failed dissolution specifications. Check your lot numbers and expiration dates.
Use caution until it’s fixed
Failed Dissolution Specifications
Contact the company
What happened, in plain English
The Harvard Drug Group has recalled Paliperidone Extended-Release Tablets, 9 mg, because the medication failed to meet dissolution specifications. This means the drug may not release its active ingredient properly, potentially affecting how well it works for patients. The recall affects 174 cartons distributed nationwide. Read more at govinfonow.com/recall/35204-harvard-drug-recalls-paliperidone-9mg-tablets-for-dissolution-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/35204-harvard-drug-recalls-paliperidone-9mg-tablets-for-dissolution-failure · Updated October 10, 2026 · FDA enforcement record: FDA #D-0649-2022
Cite this page
“Harvard Drug Recalls Paliperidone 9mg Tablets for Dissolution Failure.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/35204-harvard-drug-recalls-paliperidone-9mg-tablets-for-dissolution-failure. Based on FDA recall #D-0649-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0649-2022%22&limit=1).
Why it’s dangerous
The tablets failed dissolution specifications, which is a quality control measure ensuring the drug releases at the correct rate. If the drug does not dissolve as intended, patients may receive less medication than prescribed, leading to inadequate treatment of their condition.
Who’s affected
Patients currently taking Paliperidone Extended-Release Tablets, 9 mg, specifically those who purchased the recalled lots from pharmacies or distributors nationwide. Individuals with prescriptions filled before the recall date are most likely affected.
How to tell if you have this one
Check your medication bottle for NDC 0904-6937-61. Look for Lot numbers N00522 (Expiration Date 09/2022) or N00618 (Expiration Date 11/2022). The product is manufactured by Sun Pharmaceutical Industries Ltd. and distributed by Major Pharmaceuticals.
- Brand
The Harvard Drug Group- Category
Drug
What to do — step by step
Check Your Medication
Verify if your Paliperidone tablets match the recalled NDC, lot numbers, or expiration dates listed in the record.
Contact Your Pharmacist
If you have the recalled product, contact your pharmacist or healthcare provider for instructions on replacement or disposal.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 15 months 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-0649-2022 (February 28, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0649-2022 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 10, 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.