MAJOR PHARMACEUTICALS recalls Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC#
Major Pharmaceuticals recalls 80mg Valsartan tablets (Rx only) due to detected carcinogen impurity in manufacturing. Affected lots include T-01270 through T-01807 with specific expiry dates.
Stop using this now
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Contact the company & request your remedy
What happened, in plain English
Major Pharmaceuticals has recalled 80mg Valsartan tablets (Rx only) because a carcinogen impurity was found in the drug product. This recall affects specific lots manufactured between July 2018 and May 2019, and users should stop using the product if they have it. Read more at govinfonow.com/recall/40334-major-pharmaceuticals-recalls-80mg-valsartan-tablets-due-to-carcinogen-impurity.
Source Summary by GovInfoNow · govinfonow.com/recall/40334-major-pharmaceuticals-recalls-80mg-valsartan-tablets-due-to-carcinogen-impurity · Updated October 6, 2026 · FDA enforcement record: FDA #D-0966-2018
Cite this page
“Major Pharmaceuticals Recalls 80mg Valsartan Tablets Due to Carcinogen Impurity.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/40334-major-pharmaceuticals-recalls-80mg-valsartan-tablets-due-to-carcinogen-impurity. Based on FDA recall #D-0966-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0966-2018%22&limit=1).
Why it’s dangerous
The drug product contains a carcinogen impurity that was detected during manufacturing. This impurity could potentially cause cancer with long-term use, making the product unsafe for patients.
Who’s affected
People who have the recalled 80mg Valsartan tablets (Rx only) from Major Pharmaceuticals. Those with the specific lot numbers listed in the recall are most at risk.
How to tell if you have this one
Check the lot number on the tablet packaging. The affected lots are T-01270 through T-01807 with expiry dates from July 2018 to May 2019.
- Brand
Major Pharmaceuticals- 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
Terminated- Distribution
Nationwide.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0966-2018 | Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.; Major Label Unit Dose 10 x 10 Cartons 80 mg Item # 302086. Lot# T-01270 (Expiry: 7/18). Lot# T-01466 (Expiry: 7/18). Lot# T-01500 (Expiry:2/19). Lot# T-01596 (Expiry: 2/19). Lot# T-01625 (Expiry: 2/19). Lot# T-01712 (Expiry: 2/19). Lot# T-01795 (5/19). Lot# T-01807 (Expiry: 5/19). | 5,464 cartons |
| D-0967-2018 | Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61.; Major Label Unit Dose 10 x 10 Cartons 160 mg Item # 302087. Lot# T-01269 (Expiry: 7/18). Lot# T-01524 (Expiry: 2/19). Lot# T-01646 (Expiry: 5/19). Lot# T-01668 (Expiry: 5/19). Lot# T-01788 (Expiry: 5/19). | 4,556 cartons |
What to do — step by step
Stop Using Now
Immediately stop using the recalled 80mg Valsartan tablets if you have them.
Questions people ask
What is the specific lot number range for the recalled tablets?
The affected lots are T-01270 through T-01807 with expiry dates from July 2018 to May 2019.
Do I need to contact a doctor if I have the recalled tablets?
The recall record does not specify whether medical consultation is needed.
How can I confirm if my tablets are part of this recall?
Check the lot number on the tablet packaging; affected lots are T-01270 through T-01807 with specific expiry dates.
Contact Major Pharmaceuticals
We’ve drafted a message you can send Major Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0966-2018 — Major Pharmaceuticals Major Pharmaceuticals Hello, I own a Major Pharmaceuticals that is covered by recall D-0966-2018 from Major Pharmaceuticals. 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-0966-2018 (July 18, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0966-2018 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.