AVKARE Inc. recalls Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc.
AVKARE recalls 40mg Valsartan tablets due to detected carcinogen impurity in manufacturing. Affected lots expire 10/2018 to 10/2019. No specific remedy provided in recall notice.
Recall notice
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Contact the company & request your remedy
What happened, in plain English
AVKARE has recalled 40mg Valsartan tablets that contain a carcinogen impurity. This poses a potential cancer risk with long-term use, so affected individuals should stop using the product and contact the manufacturer. Read more at govinfonow.com/recall/39726-avkare-valsartan-tablets-40mg-recall-carcinogen-impurity-detected.
Source Summary by GovInfoNow · govinfonow.com/recall/39726-avkare-valsartan-tablets-40mg-recall-carcinogen-impurity-detected · Updated October 6, 2026 · FDA enforcement record: FDA #D-1130-2018
Cite this page
“AVKARE Valsartan Tablets 40mg Recall: Carcinogen Impurity Detected.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39726-avkare-valsartan-tablets-40mg-recall-carcinogen-impurity-detected. Based on FDA recall #D-1130-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1130-2018%22&limit=1).
Why it’s dangerous
The drug product contains a carcinogen impurity that was detected during manufacturing. This impurity could potentially lead to cancer with long-term use of the medication. The impurity was found in the active pharmaceutical ingredient used to make the tablets.
Who’s affected
People who have the specific lot numbers of Valsartan tablets (NDC 50268-783-15) manufactured for AvKARE, Inc. in Pulaski, TN between 2018 and 2019. Those taking this medication for blood pressure should be most at risk.
How to tell if you have this one
Check the product label for the NDC code 50268-783-15 and lot numbers 18491 through 21635. The tablets expire between October 2018 and October 2019.
- Brand
AVKARE- Category
Drug
All 4 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
U.S. Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1130-2018 | Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478; Lots: 18491 Exp. 10/2018; 19531 Exp. 04/2019; 20168 Exp. 05/2019; 20671 Exp. 08/2019; 21049 Exp. 10/2019; 21635 Exp. 10/2019 | 6776 cartons (338,800 tablets) |
| D-1131-2018 | Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478; Lots: 18492 Exp. 11/2018; 20169 Exp. 05/2019 | 728 cartons (36,400 tablets) |
| D-1132-2018 | Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478; Lots: 17717 Exp. 07/2018; 18493 Exp. 01/2019; 19761 Exp. 04/2019 | 818 cartons (40,900 tablets) |
| D-1133-2018 | Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski, TN 38478; Lots: 17718 Exp. 07/2018; 18700 Exp. 01/2019; 19133 Exp. 02/2019; 19532 Exp. 04/2019 | 1496 cartons (44,880 tablets) |
What to do — step by step
Check Product Label
Look for the NDC code 50268-783-15 and lot numbers 18491 through 21635 on the tablet packaging.
Questions people ask
Is this product safe to use?
The recall notice states a carcinogen impurity was detected, so the product is not safe for use. Affected individuals should stop using it.
What should I do if I have these tablets?
The recall notice does not specify a remedy, so contact AVKARE directly for guidance.
Are there any other products affected?
The recall only affects the specific Valsartan tablets with the NDC code 50268-783-15 and listed lot numbers.
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-1130-2018 — AVKARE AVKARE Hello, I own a AVKARE that is covered by recall D-1130-2018 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-1130-2018 (August 14, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1130-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.