AVKARE Inc. recalls Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc.
FDA recalls AVKARE Losartan Potassium Tablets due to impurity NMBA above safe levels. Consumers should check NDC 50268-517-15 for affected units.
Recall notice
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.
Contact the company & request your remedy
What happened, in plain English
AVKARE Inc. is recalling Losartan Potassium Tablets (50 mg, 50 tablets) because FDA testing found an impurity (NMBA) at levels above the safe limit. This could pose a health risk if taken regularly. Read more at govinfonow.com/recall/38878-avkare-losartan-tablets-recall-impurity-risk-in-drug-product.
Source Summary by GovInfoNow · govinfonow.com/recall/38878-avkare-losartan-tablets-recall-impurity-risk-in-drug-product · Updated October 5, 2026 · FDA enforcement record: FDA #D-1249-2019
Cite this page
“AVKARE Losartan Tablets Recall: Impurity Risk in Drug Product.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38878-avkare-losartan-tablets-recall-impurity-risk-in-drug-product. Based on FDA recall #D-1249-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1249-2019%22&limit=1).
Why it’s dangerous
The FDA confirmed the presence of N-Methylnitrosobutyric acid (NMBA) in the tablets at levels exceeding the acceptable daily intake limit. This impurity could potentially cause health issues with long-term use, though the exact risk is not fully specified.
Who’s affected
People who have been prescribed these specific Losartan tablets by a doctor. Those taking the medication for blood pressure or kidney issues are most at risk.
How to tell if you have this one
Check for the NDC code 50268-517-15 on the tablet packaging. The product was manufactured in Pulaski, TN and expires June 30, 2019.
- Brand
AVKARE- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1249-2019 | Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478; Lot: 20121 Exp. 6/30/2019 | 1438 cartons (71,900 tablets) |
| D-1250-2019 | Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478; Lot: 19554 Exp. 4/30/2019 | 846 cartons (42,300 tablets) |
What to do — step by step
Check Product Details
Look for the NDC code 50268-517-15 on the tablet packaging to confirm if you have the recalled product.
Questions people ask
Is this product safe to take?
The FDA confirmed the presence of an impurity above safe levels, but the exact health risk is not fully specified in the recall notice.
How can I tell if I have the recalled product?
Check for the NDC code 50268-517-15 on the tablet packaging. The product was manufactured in Pulaski, TN and expires June 30, 2019.
What should I do if I have the recalled product?
The recall notice does not specify a remedy, so contact your doctor or the manufacturer for guidance.
Contact AVKARE
We’ve drafted a message you can send AVKARE to request your refund or repair — edit it as you like.
Subject: Recall D-1249-2019 — AVKARE AVKARE Hello, I own a AVKARE that is covered by recall D-1249-2019 from AVKARE. 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-1249-2019 (April 24, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1249-2019 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.