Harvard Drug Group Recalls Oxycodone Due to Double Dosing Hazard
The Harvard Drug Group is recalling specific lots of 5 mg oxycodone tablets because some blister cards may contain two pills instead of one, posing a serious overdose risk.
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Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 OXYCODONE HCl 5 mg tablets.
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What happened, in plain English
The Harvard Drug Group, LLC has recalled OXYCODONE HCl C-II Tablets, 5 mg USP, distributed by Major Pharmaceuticals. The recall was initiated after confirmed customer complaints that certain units contained two tablets in a single blister cavity meant for one dose. This error creates a significant risk of accidental overdose. Read more at govinfonow.com/recall/44177-the-harvard-drug-group-llc-recalls-oxycodone-hcl-c-ii.
Source Summary by GovInfoNow · govinfonow.com/recall/44177-the-harvard-drug-group-llc-recalls-oxycodone-hcl-c-ii · Updated October 12, 2026 · FDA enforcement record: FDA #D-1150-2015
Cite this page
“Harvard Drug Group Recalls Oxycodone Due to Double Dosing Hazard.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44177-the-harvard-drug-group-llc-recalls-oxycodone-hcl-c-ii. Based on FDA recall #D-1150-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1150-2015%22&limit=1).
Why it’s dangerous
The hazard is a manufacturing defect where a single blister cavity contains two 5 mg tablets instead of the intended one. Taking two tablets when only one was prescribed can lead to a serious overdose, which is particularly dangerous for a potent opioid like oxycodone.
Who’s affected
Patients currently taking this specific prescription medication are at immediate risk of receiving an incorrect, double dose. Anyone who has filled a prescription with the identified lot numbers should check their medication immediately.
How to tell if you have this one
Check your medication packaging for the following details: NDC 0904-6444-61, Lot # P-20000 or Lot # P-20004, and an expiration date of 08/16. The product is a 100-count blister card of Rx-only tablets manufactured by Nesher Pharmaceuticals USA LLC.
- Brand
The Harvard Drug Group- Category
Drug
What to do — step by step
Stop taking the medication
Do not consume any tablets from the recalled lots due to the risk of double dosing.
Contact your pharmacy or doctor
Inform your healthcare provider and pharmacist about the recall so they can assist you with a replacement or alternative treatment.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “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 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.
Questions people ask
What is the NDC number for the recalled product?
The National Drug Code (NDC) for the affected product is 0904-6444-61.
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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-1150-2015 (June 10, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1150-2015 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 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.