UnratedDrug recall · FDA · Published April 22, 2019
RemedyRepack Losartan/HCTZ Tablets Recall: Impurity Risk in Drug Product
FDA-confirmed impurity in Losartan Potassium/HCTZ tablets may exceed safe levels. Recalled batch: NDC 70518-1560-00, Lot B05170:101618, expiring 10/2019. Consumers should contact manufacturer for details.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
Take action
Contact the company
📍Recalling firmRemedyRepack Inc.625 Kolter Dr Ste 4 · Indiana, PA 15701-3571
“RemedyRepack Losartan/HCTZ Tablets Recall: Impurity Risk in Drug Product.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38895-remedyrepack-losartan-hctz-tablets-recall-impurity-risk-in-drug-product. Based on FDA recall #D-1270-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1270-2019%22&limit=1).
The FDA announced on April 22, 2019, that RemedyRepack Inc. voluntarily recalled Losartan Potassium/HCTZ tablets due to CGMP deviations confirmed by an FDA lab. The product contained N-Methylnitrosobutyric acid above the acceptable daily intake level.
FDA lab testing confirmed the presence of an impurity, N-Methylnitrosobutyric acid (NMBA), in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
Context
GovInfoNow's records show RemedyRePack Inc. has 35 other recalls on record since February 18, 2015. Recent brand recalls include Clindamycin Capsules recalled on April 22, 2025, and March 24, 2025, due to CGMP deviations, as well as Carvedilol Tablets recalled on January 24, 2025, for N-Nitroso Impurity Risk. Other recent recalls of similar products include Duloxetine Capsules (May 14, 2026), Bisoprolol/Hydrochlorothiazide Tablets (January 21, 2026), and Duloxetine Capsules (April 21, 2026).
How to tell if you have this one
Check for the 90-count bottle labeled 'Losartan Potassium/HCTZ, 100 mg/12.5 mg' with NDC 70518-1560-00. The lot number is B0517068-101618 and it expires on 10/2019.
Brand
RemedyRepack
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the NDC number 70518-1560-00 and lot number B0517068-101618 on the bottle.
Where it went and when
Where it was distributed
Distributed in Florida.
Listed by the agency
Not listed
FDA distribution: “Product was distributed to Florida.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1270-2019 (April 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1270-2019 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 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.