Sandoz Amoxicillin-Clavulanate Tablets Recall: Subpotent Clavulanic Acid Risk
Sandoz recalls 500mg/125mg amoxicillin-clavulanate tablets (20-count) due to subpotent clavulanic acid. This may reduce effectiveness of the antibiotic. Contact Sandoz for details.
Lower-risk recall
Subpotent Drug; Clavulanic Acid
Contact the company
What happened, in plain English
Sandoz is recalling 500 mg/125 mg amoxicillin-clavulanate potassium tablets (20-count bottles) because they contain less clavulanic acid than labeled. This could make the antibiotic less effective at treating infections. Read more at govinfonow.com/recall/41639-sandoz-amoxicillin-clavulanate-tablets-recall-subpotent-clavulanic-acid-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41639-sandoz-amoxicillin-clavulanate-tablets-recall-subpotent-clavulanic-acid-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0868-2017
Cite this page
“Sandoz Amoxicillin-Clavulanate Tablets Recall: Subpotent Clavulanic Acid Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41639-sandoz-amoxicillin-clavulanate-tablets-recall-subpotent-clavulanic-acid-risk. Based on FDA recall #D-0868-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0868-2017%22&limit=1).
Why it’s dangerous
The tablets contain less clavulanic acid than specified, which reduces the antibiotic's ability to work effectively against certain bacteria. This could lead to treatment failure for infections that require this combination.
Who’s affected
Prescription patients who have received this specific tablet product. Those with infections requiring antibiotic treatment may be at risk of reduced effectiveness.
How to tell if you have this one
Look for 20-count bottles labeled 'Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg' with NDC 0781-1831-20. The lot number FP8735 was manufactured in August 2017.
- Brand
Sandoz- Category
Drug
What to do — step by step
Check Your Medication
Verify if your prescription contains the specific 20-count bottle with NDC 0781-1831-20 and lot number FP8735.
Where it went and when
Where it was distributed
Distributed in New York and Ohio.
FDA distribution: “NY, OH” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New York, Ohio.
Recall timeline
FDA terminated this recall 2.3 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-0868-2017 (April 26, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0868-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.