Unrated Drug recall · FDA · Published March 14, 2019

RemedyRePack Losartan 5: Risk of Impurity in Tablets

RemedyRePack recalls Losartan 50mg tablets due to trace impurities detected in manufacturing. Affected lots may pose health risks; contact for return instructions.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1081-2019Drug RemedyRePack ›

Recall notice

CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).

Take action

Contact the company

Recalling firmRemedyRepack Inc.625 Kolter Dr Ste 4 · Indiana, PA 15701-3571

✎ GovInfoNow plain-language explainer

RemedyRePack is recalling Losartan 50mg tablets because a small amount of an unexpected chemical was found during production. This could potentially cause health issues if taken by people who need the medication. Read more at govinfonow.com/recall/39088-remedyrepack-losartan-5-risk-of-impurity-in-tablets.

Source Summary by GovInfoNow · govinfonow.com/recall/39088-remedyrepack-losartan-5-risk-of-impurity-in-tablets · Updated October 5, 2026 · FDA enforcement record: FDA #D-1081-2019

Cite this page

“RemedyRePack Losartan 5: Risk of Impurity in Tablets.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39088-remedyrepack-losartan-5-risk-of-impurity-in-tablets. Based on FDA recall #D-1081-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1081-2019%22&limit=1).

RemedyRePack Inc. voluntarily recalled Losartan 50mg Tablets due to CGMP deviations involving an unexpected impurity, according to the FDA on March 14, 2019.

How to tell if you have it

Brand: RemedyRePack
Product: Losartan 50mg Tablet, 30 count each blister card
UPC: 70518-0588-01
Lot #: J0328416-101518
Exp. Date: 10/2019
Distribution: Miami, FL

The hazard

The recall addresses CGMP deviations and the detection of trace amounts of an unexpected impurity found in the active pharmaceutical ingredient N-Methylnitrosobutyric acid (NMBA).

Context

GovInfoNow's records show RemedyRePack Inc. has 35 other recalls on record since Feb. 18, 2015. Other recent recalls of similar products include Macleods Olanzapine Tablets 5mg Recall (Aug. 27, 2026), Ajanta Pharma Recalls Duloxetine Capsules Due to Nitrosamine Impurity Risk (April 29, 2026), and Zydus Mirabegron 25mg Tablets Recall (Aug. 5, 2026).

How to tell if you have this one

Check for the product name 'Losartan 50mg Tablet, 30 count each blister card' with lot number J0328416-101518. The expiration date is October 2019.

Brand
RemedyRePack
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the lot number J0328416-101518 on the blister card.

Where it went and when

Where it was distributed

Distributed in Florida.

FDA distribution: “Product was distributed to one sole customer, Miami, FL.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida.

Recall timeline

FDA terminated this recall 28 days after the firm started it.

Mar 14, 2019Firm started the recall
Apr 5, 2019FDA classified it Class II
Apr 11, 2019FDA terminated the recall
Apr 17, 2019Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/39088-remedyrepack-losartan-5-risk-of-impurity-in-tablets">RemedyRePack Losartan 5: Risk of Impurity in Tablets (GovInfoNow)</a>

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-1081-2019 (March 14, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1081-2019 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.