Legacy Pharmaceutical Packaging LLC recalls Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: The Kroger Co, Cincinnati, OH
Legacy Pharmaceutical Packaging LLC recalls 50mg Losartan Potassium Tablets due to trace NMBA impurity detected in the active ingredient. This may pose health risks. Consumers should contact the manufacturer for details.
Recall notice
CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
Contact the company & request your remedy
What happened, in plain English
Legacy Pharmaceutical Packaging LLC is recalling 50mg Losartan Potassium Tablets because trace amounts of a potentially harmful chemical called NMBA were found in the active ingredient. This recall is for prescription-only bottles distributed by The Kroger Co. Read more at govinfonow.com/recall/38880-legacy-pharmaceutical-losartan-tablets-recall-nmba-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/38880-legacy-pharmaceutical-losartan-tablets-recall-nmba-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1263-2019
Cite this page
“Legacy Pharmaceutical Losartan Tablets Recall: NMBA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38880-legacy-pharmaceutical-losartan-tablets-recall-nmba-impurity-risk. Based on FDA recall #D-1263-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1263-2019%22&limit=1).
Why it’s dangerous
The recall involves trace amounts of NMBA, a chemical that can be harmful when present in medications. While the exact health risk isn't specified, the presence of this impurity in the active pharmaceutical ingredient raises concerns about potential health effects.
Who’s affected
Prescription patients who have received the recalled 50mg Losartan Potassium Tablets from The Kroger Co. Those with specific health conditions may be at higher risk due to the impurity.
How to tell if you have this one
Check for 50mg Losartan Potassium Tablets, USP, 30-count bottles with NDC 68645-494-54, Lot 181598, and a 02/2021 expiration date. These were distributed by The Kroger Co.
- Brand
Legacy Pharmaceutical Packaging LLC- Category
Drug
What to do — step by step
Contact Manufacturer
Reach out to Legacy Pharmaceutical Packaging LLC for specific instructions on handling the recalled product.
Questions people ask
Is this product safe to use?
The recall states trace NMBA impurity was detected, but the official notice does not specify if the product is safe to use.
How can I check if I have the recalled product?
Look for 50mg Losartan Potassium Tablets, USP, 30-count bottles with NDC 68645-494-54, Lot 181598, and a 02/2021 expiration date.
What should I do if I have the recalled product?
The official notice does not specify a remedy, so contact Legacy Pharmaceutical Packaging LLC for instructions.
Contact Legacy Pharmaceutical Packaging LLC
We’ve drafted a message you can send Legacy Pharmaceutical Packaging LLC to request your refund or repair — edit it as you like.
Subject: Recall D-1263-2019 — Legacy Pharmaceutical Packaging LLC Legacy Pharmaceutical Packaging LLC Hello, I own a Legacy Pharmaceutical Packaging LLC that is covered by recall D-1263-2019 from Legacy Pharmaceutical Packaging LLC. 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-1263-2019 (April 24, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1263-2019 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.