H J Harkins Company Inc dba Pharma Pac recalls Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear
Pharma Pac recalls Losartan Potassium 100mg tablets due to traces of NMBA impurity found in the active ingredient. Affected products have specific NDC and lot numbers. Consumers should contact the company for details.
Recall notice
CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
Contact the company & request your remedy
What happened, in plain English
Pharma Pac is recalling Losartan Potassium 100mg tablets because they contain traces of a harmful chemical impurity (NMBA) that could pose health risks. This recall affects specific batches of the medication that were manufactured between November 2019 and early 2020. Read more at govinfonow.com/recall/39133-pharma-pac-losartan-potassium-100mg-tablets-recall-nmba-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39133-pharma-pac-losartan-potassium-100mg-tablets-recall-nmba-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1083-2019
Cite this page
“Pharma Pac Losartan Potassium 100mg Tablets Recall: NMBA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39133-pharma-pac-losartan-potassium-100mg-tablets-recall-nmba-impurity-risk. Based on FDA recall #D-1083-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1083-2019%22&limit=1).
Why it’s dangerous
The recall is due to traces of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) found in the active pharmaceutical ingredient. This impurity could potentially cause health issues, though the exact risk level is not clearly specified in the recall notice.
Who’s affected
People who have the specific batch of Losartan Potassium 100mg tablets with NDC 76519-1033-03 and lot number LTO00EW are affected. Those taking this medication for blood pressure should be cautious.
How to tell if you have this one
Check for tablets that are white to off-white, film-coated, and have "H" on one side and "145" on the other. The specific batch has NDC 76519-1033-03 and lot number LTO00EW.
- Brand
Pharma Pac- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 76519-1033-03 and lot number LTO00EW on the packaging.
Questions people ask
Why is this medication being recalled?
The recall is due to traces of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) impurity found in the active pharmaceutical ingredient.
What should I do if I have this medication?
The recall notice does not specify a remedy, so contact Pharma Pac directly for instructions.
Is this impurity dangerous?
The recall notice states that traces of NMBA were found, but does not clearly describe the health risks or severity.
Contact Pharma Pac
We’ve drafted a message you can send Pharma Pac to request your refund or repair — edit it as you like.
Subject: Recall D-1083-2019 — Pharma Pac Pharma Pac Hello, I own a Pharma Pac that is covered by recall D-1083-2019 from Pharma Pac. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-1083-2019 (March 4, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1083-2019 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.