Avkare Incorporated recalls AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE,
AvKARE recalls 90-count Valsartan and Hydrochlorothiazide tablets (Rx Only) due to detected carcinogen impurity in manufacturing. Affected lots expire 09/2018 to 08/2019.
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 is recalling 90-count tablets of Valsartan and Hydrochlorothiazide that contain a carcinogen impurity. This poses a risk of cancer exposure through long-term use of the medication. Read more at govinfonow.com/recall/40335-avkare-valsartan-hydrochlorothiazide-tablets-recall-carcinogen-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40335-avkare-valsartan-hydrochlorothiazide-tablets-recall-carcinogen-impurity-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-1176-2018
Cite this page
“AvKARE Valsartan/Hydrochlorothiazide Tablets Recall: Carcinogen Impurity Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/40335-avkare-valsartan-hydrochlorothiazide-tablets-recall-carcinogen-impurity-risk. Based on FDA recall #D-1176-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1176-2018%22&limit=1).
Why it’s dangerous
The drug manufacturing process detected a carcinogen impurity in the active ingredients. This impurity could lead to cancer exposure if the medication is taken over time.
Who’s affected
Prescription medication users who have the specific 90-count bottle with the listed expiration dates. Patients on this medication regimen are most at risk.
How to tell if you have this one
Check for the 90-count bottle labeled 'AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, Rx Only'. Look for the expiration dates listed: 09/2018 through 08/2019.
- Brand
AvKARE- Category
Drug
All 5 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 | Quantity |
|---|---|---|
| D-1173-2018 | AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-884-90; Lots: 17349 Exp. 08/2018; 18395 Exp. 08/2018; 19221 Exp. 06/2019; 20029 Exp. 06/2019; 20158 Exp. 07/2019; 20843 Exp. 07/2019; 21411 Exp. 09/2019. | 12240 bottles |
| D-1174-2018 | AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-885-90; Lots: 17325 Exp. 09/2018; 17856 Exp. 09/2018; 18396 Exp. 09/2018; 18702 Exp. 02/2019; 19020 Exp. 02/2019; 19222 Exp. 02/2019; 20030 Exp. 04/2019; 20381 Exp. 04/2019 | 24796 bottles |
| D-1175-2018 | AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-887-90; Lots: 17325 Exp. 09/2018; 17856 Exp. 09/2018; 18396 Exp. 09/2018; 18702 Exp. 02/2019; 19020 Exp. 02/2019; 19222 Exp. 02/2019; 20030 Exp. 04/2019; 20381 Exp. 04/2019 | 19109 bottles |
| D-1176-2018 | AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-886-90; Lots: 17780 Exp. 09/2018; 18029 Exp. 09/2018; 18398 Exp. 09/2018; 18723 Exp. 09/2018; 19017 Exp. 02/2019; 19224 Exp. 02/2019; 20032 Exp. 08/2019; 20289 Exp. 08/2019; 21076 Exp. 08/2019; 21382 Exp. 08/2019 | 12950 bottles |
| D-1177-2018 | AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-888-90; Lots: 17308 Exp. 09/2018; 18158 Exp. 09/2018; 18539 Exp. 01/2019; 19021 Exp. 01/2019; 19225 Exp. 01/2019; 20033 Exp. 06/2019; 20290 Exp. 06/2019; 20565 Exp. 06/2019; 21369 Exp. 10/2019 | 19623 bottles |
What to do — step by step
Check Medication Details
Identify the expiration date on the bottle, which should be between 09/2018 and 08/2019.
Questions people ask
Is this medication safe to take?
The recall states a carcinogen impurity was detected, so it is not safe for long-term use. Consult your doctor immediately.
What should I do if I have this medication?
The official recall does not specify a remedy, so contact your doctor for guidance on whether to stop using it.
How can I tell if I have the recalled product?
Check the expiration date on the bottle, which should be between 09/2018 and 08/2019.
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-1176-2018 — AvKARE AvKARE Hello, I own a AvKARE that is covered by recall D-1176-2018 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.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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-1176-2018 (July 18, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1176-2018 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.