Lupin Somerset Hydrocodone Tablets: Missing Label Hazard
Lupin Somerset recalls 5 mg/325 mg hydrocodone acetaminophen tablets due to missing labels. This could lead to incorrect dosing. Consumers should check their product details and contact the manufacturer.
Lower-risk recall
Labeling: Missing Label
Contact the company
What happened, in plain English
Lupin Somerset is recalling 1000-count hydrocodone acetaminophen tablets because the labels are missing. This means users might take the wrong dose, which could cause health issues. Read more at govinfonow.com/recall/40515-lupin-somerset-hydrocodone-tablets-missing-label-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/40515-lupin-somerset-hydrocodone-tablets-missing-label-hazard · Updated October 7, 2026 · FDA enforcement record: FDA #D-0836-2018
Cite this page
“Lupin Somerset Hydrocodone Tablets: Missing Label Hazard.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40515-lupin-somerset-hydrocodone-tablets-missing-label-hazard. Based on FDA recall #D-0836-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0836-2018%22&limit=1).
Why it’s dangerous
Missing labels could lead to incorrect dosing. Without the label, users might not know the correct dosage or expiration date, which could cause health problems.
Who’s affected
People who have the 1000-count hydrocodone acetaminophen tablets (5 mg/325 mg) from Lupin Somerset. Those who take the medication as prescribed are most at risk.
How to tell if you have this one
Check for the product name 'Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only'. The lot number is S800257 and expiration date is January 2020.
- Brand
Lupin Somerset- Product
Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel- Category
Drug
What to do — step by step
Check Product Details
Look for the product name, lot number S800257, and expiration date of January 2020 on the packaging.
Where it went and when
Where it was distributed
Distributed in Ohio.
FDA distribution: “OH” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Ohio.
Recall timeline
FDA terminated this recall 2.7 years 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-0836-2018 (May 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0836-2018 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.