RemedyRePack recalls Amlodipine/Valsartan HCTZ tablets with trace NDMA impurity
RemedyRePack recalls 10 mg/320 mg/25 mg Amlodipine/Valsartan HCTZ tablets in HDPE bottles due to trace NDMA impurity detected in manufacturing.
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 certain blood pressure medication tablets that contain trace amounts of NDMA, a possible impurity. This could pose a health risk, so affected consumers should stop using the product and contact the manufacturer. Read more at govinfonow.com/recall/39683-remedyrepack-recalls-amlodipine-valsartan-hctz-tablets-with-trace-ndma-impurity.
Source Summary by GovInfoNow · govinfonow.com/recall/39683-remedyrepack-recalls-amlodipine-valsartan-hctz-tablets-with-trace-ndma-impurity · Updated October 6, 2026 · FDA enforcement record: FDA #D-0093-2019
Cite this page
“RemedyRePack recalls Amlodipine/Valsartan HCTZ tablets with trace NDMA impurity.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39683-remedyrepack-recalls-amlodipine-valsartan-hctz-tablets-with-trace-ndma-impurity. Based on FDA recall #D-0093-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0093-2019%22&limit=1).
Why it’s dangerous
The recall is due to trace amounts of NDMA, a possible impurity, found in the medication during manufacturing. NDMA has been linked to potential health risks, though the exact risk level is not fully defined in this recall.
Who’s affected
People who own or use the recalled Amlodipine/Valsartan HCTZ tablets with the specific NDC number 13668-0325-30 are affected. Those with high blood pressure or on this medication are most at risk.
How to tell if you have this one
Check for the product name 'Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets' in HDPE 90 cc bottles with the original NDC 13668-0325-30. The repackaged version has NDC 70518-1220-00 and lot number B0438903-052118.
- Brand
RemedyRePack- Category
Drug
What to do — step by step
Stop Using Product
Immediately stop using the recalled tablets and contact RemedyRePack for instructions.
Where it went and when
Where it was distributed
Distributed in South Carolina.
FDA distribution: “Product was distributed to a medical facility in 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 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- FDA terminated the recall
- Published in FDA’s Enforcement Report
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-0093-2019 (August 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0093-2019 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.