A-S Medication Solutions LLC. recalls Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx
A-S Medication Solutions recalls Valsartan 320mg and Hydrochlorothiazide 25mg tablets due to detected carcinogen impurity in manufacturing. Affected lots from 2018-2019.
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
A-S Medication Solutions is recalling Valsartan 320mg and Hydrochlorothiazide 25mg tablets because a carcinogen was found in the manufacturing process. This could pose a cancer risk to users taking these medications. Read more at govinfonow.com/recall/40349-recall-valsartan-hydrochlorothiazide-tablets-with-carcinogen-impurity.
Source Summary by GovInfoNow · govinfonow.com/recall/40349-recall-valsartan-hydrochlorothiazide-tablets-with-carcinogen-impurity · Updated October 6, 2026 · FDA enforcement record: FDA #D-1111-2018
Cite this page
“Recall: Valsartan/Hydrochlorothiazide Tablets with Carcinogen Impurity.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/40349-recall-valsartan-hydrochlorothiazide-tablets-with-carcinogen-impurity. Based on FDA recall #D-1111-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1111-2018%22&limit=1).
Why it’s dangerous
The recall is for a carcinogen impurity detected during manufacturing. This means the medication could contain a cancer-causing substance that might increase cancer risk when taken over time.
Who’s affected
People who have prescription Valsartan 320mg and Hydrochlorothiazide 25mg tablets from the listed lots and expiration dates. Those taking these medications for blood pressure or other conditions are most at risk.
How to tell if you have this one
Check your prescription bottle for the NDC code 54569-6488-0. Look for specific lot numbers and expiration dates listed in the recall notice: 1/31/2019, 6/30/2019, and 9/30/2018.
- Brand
A-S Medication Solutions- 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
Ongoing- Distribution
Nationwide USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1108-2018 | Valsartan Tablets, 160 MG, 30-count bottle (NDC 54569-6583-0), 90-count bottle (NDC 54569-6583-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China; Expiry, lot: [30-count] 2/28/2019: 7285177; 3/31/2019: 7222163, 7227175; 8/31/2019: 8162190, 8183227. [90-count] 2/28/2019: 7207135, 7212280, 7215073; 3/31/2019: 7222162; 8/31/2019: 8095248, 8095249 | 666 bottles |
| D-1109-2018 | Valsartan Tablets, 80 MG, 30-count bottle (NDC 54569-6582-0, 90-count bottle (NDC 54569-6582-1), Rx Only, MFG: Zhejiang Huahai Pharma, Linhai, Zhejiang 317024 China; Expiry, lot: [30-count] 11/30/2018: 7258177, 7276228; 2/28/2019: 7212260; [90-count] 11/30/2018: 7208140; 2/28/2019: 7212261, 7221155, 7222161; 8/31/2019: 8109171; 9/30/2019: 8109170 | 178 bottles |
| D-1110-2018 | Valsartan and Hydrochlorothiazide Tablets, Valsartan 160 MG and Hydrochlorothiazide 12.5 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6480-0; Expiry, lot: 4/30/2019: 8033130; 7/31/2019: 8068192, 8110183, 8080157, 8190195 | 524 bottles |
| D-1111-2018 | Valsartan and Hydrochlorothiazide Tablets, Valsartan 320 MG and Hydrochlorothiazide 25 MG, 90 tablets per bottle, Rx Only, MFG: Arrow Pharm (Malta) LTD, Birzebbugia, BBG 3000 Malta. NDC: 54569-6488-0; Expiry, lot: 1/31/2019: 7293219; 6/30/2019: 7362231, 8074161, 8110184, 8197215, 8114178, 8115123; 9/30/2018: 7132187, 7160161, 7180150, 7268239 | 531 bottles |
What to do — step by step
Check Your Medication
Verify your prescription bottle has the NDC code 54569-6488-0 and the listed lot numbers and expiration dates.
Questions people ask
Is this medication safe to take?
The recall states a carcinogen impurity was detected, so these specific tablets are not safe. Do not take them.
What should I do if I have these tablets?
Contact your healthcare provider for guidance on alternative medications. Do not use the recalled tablets.
Are there any specific lot numbers I should avoid?
Yes, avoid the specific lot numbers listed: 7293219, 7362231, 8074161, 8110184, 8197215, 8114178, 8115123 for 6/30/2019, and 7132187, 7160161, 7180150, 7268239 for 9/30/2018.
Contact A-S Medication Solutions
We’ve drafted a message you can send A-S Medication Solutions to request your refund or repair — edit it as you like.
Subject: Recall D-1111-2018 — A-S Medication Solutions A-S Medication Solutions Hello, I own a A-S Medication Solutions that is covered by recall D-1111-2018 from A-S Medication Solutions. 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-1111-2018 (July 17, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1111-2018 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.