RemedyRePack recalls Amlodipine/Valsartan/HCTZ tablets with trace NDMA impurity
RemedyRePack recalls 10mg/320mg/25mg Amlodipine/Valsartan/HCTZ tablets (Rx only) due to trace NDMA impurity detected in manufacturing. Consumers should contact the company for details.
Recall notice
CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Contact the company
What happened, in plain English
RemedyRePack is recalling a specific prescription blood pressure medication because trace amounts of NDMA, a potential contaminant, were found during manufacturing. This recall affects patients taking this medication and requires them to stop using the product and contact the company for a replacement. Read more at govinfonow.com/recall/39711-remedyrepack-recalls-amlodipine-valsartan-hctz-tablets-with-trace-ndma-impurity.
Source Summary by GovInfoNow · govinfonow.com/recall/39711-remedyrepack-recalls-amlodipine-valsartan-hctz-tablets-with-trace-ndma-impurity · Updated October 6, 2026 · FDA enforcement record: FDA #D-1146-2018
Cite this page
“RemedyRePack recalls Amlodipine/Valsartan/HCTZ tablets with trace NDMA impurity.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39711-remedyrepack-recalls-amlodipine-valsartan-hctz-tablets-with-trace-ndma-impurity. Based on FDA recall #D-1146-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1146-2018%22&limit=1).
Why it’s dangerous
The recall is due to trace amounts of NDMA being detected in the medication during manufacturing. NDMA is a possible impurity that has been linked to potential health risks, though the exact risk level is not specified in the recall notice.
Who’s affected
Prescription patients taking this specific blood pressure medication are affected. Those with the medication's NDC number 70518-1220-0 and lot number B0476653-080218 are most at risk.
How to tell if you have this one
Check for the product name 'Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet' with NDC number 70518-1220-0 and lot number B0476653-080218.
- Brand
RemedyRePack- Category
Drug
What to do — step by step
Stop using the product
Discontinue use of the recalled medication immediately as it contains trace amounts of NDMA.
Where it went and when
Where it was distributed
Distributed in South Carolina.
FDA distribution: “South Carolina” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: South Carolina.
Recall timeline
FDA terminated this recall 51 days 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-1146-2018 (August 20, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1146-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.