AVKARE Inc. recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only
AVKARE recalls 50-tablet unit dose boxes of losartan-hydrochlorothiazide tablets due to an impurity (NMBA) found during manufacturing. This could pose health risks to users.
Recall notice
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Contact the company & request your remedy
What happened, in plain English
AVKARE is recalling losartan potassium and hydrochlorothiazide tablets (100 mg/12.5 mg) that were manufactured with an impurity called NMBA. This impurity could pose health risks to users who take the medication. Read more at govinfonow.com/recall/39129-avkare-losartan-hydrochlorothiazide-tablets-recall-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39129-avkare-losartan-hydrochlorothiazide-tablets-recall-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1046-2019
Cite this page
“AVKARE Losartan-Hydrochlorothiazide Tablets Recall: Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39129-avkare-losartan-hydrochlorothiazide-tablets-recall-impurity-risk. Based on FDA recall #D-1046-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1046-2019%22&limit=1).
Why it’s dangerous
The recall involves an impurity called NMBA found during manufacturing. This impurity could potentially cause health risks when taken by users, though the exact risk level is not specified in the recall notice.
Who’s affected
People who have prescription losartan-hydrochlorothiazide tablets from this manufacturer are affected. Those with hypertension or kidney conditions may be at higher risk.
How to tell if you have this one
Check for unit dose boxes labeled 'Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10)'. The NDC code 50268-514-15 and lot number 19326 (expiring 03/31/2019) are specific identifiers.
- Brand
AVKARE- Category
Drug
All 3 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
Terminated- Distribution
Nationwide.
| Recall number | Product, codes & lots |
|---|---|
| D-1044-2019 | Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15; Lots: 20961 Exp. 09/2019; 20477 Exp. 08/2019 |
| D-1045-2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15; Lot: 19454 Exp. 04/30/2019 |
| D-1046-2019 | Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15; Lot: 19326 Exp. 03/31/2019 |
What to do — step by step
Check Product Details
Identify the product by checking the NDC code 50268-514-15 and lot number 19326 on the packaging.
Questions people ask
Is this product safe to take?
The recall notice states that the product was manufactured with an impurity (NMBA), but it does not specify if the product is safe to take. The manufacturer has recalled it, so it is recommended to stop using it.
What should I do if I have this product?
The recall notice does not provide specific instructions for what to do with the product. You should check with your healthcare provider or the manufacturer for guidance.
How can I confirm if I have the recalled product?
Look for the NDC code 50268-514-15 and lot number 19326 on the packaging of the unit dose boxes.
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-1046-2019 — AVKARE AVKARE Hello, I own a AVKARE that is covered by recall D-1046-2019 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-1046-2019 (March 5, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1046-2019 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.