H J Harkins Company Inc dba Pharma Pac recalls Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC
Pharma Pac recalls 160mg Valsartan tablets due to detected carcinogen impurity in manufacturing. Affected products have specific labeling and lot numbers. Consumers should contact the company for details.
Recall notice
Carcinogen impurity detected in API used to manufacture drug product.
Contact the company & request your remedy
What happened, in plain English
Pharma Pac is recalling 160mg Valsartan tablets that contain a carcinogen impurity. This poses a health risk, especially for long-term users, as the impurity could increase cancer risk. Read more at govinfonow.com/recall/39845-pharma-pac-valsartan-tablets-160mg-recall-carcinogen-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39845-pharma-pac-valsartan-tablets-160mg-recall-carcinogen-impurity-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-1022-2018
Cite this page
“Pharma Pac Valsartan Tablets 160mg Recall: Carcinogen Impurity Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39845-pharma-pac-valsartan-tablets-160mg-recall-carcinogen-impurity-risk. Based on FDA recall #D-1022-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1022-2018%22&limit=1).
Why it’s dangerous
The tablets contain a carcinogen impurity detected during manufacturing. This impurity could increase cancer risk over time, especially with regular use of the medication.
Who’s affected
People who have the specific 160mg Valsartan tablets with the described labeling and lot numbers. Those taking the medication for chronic conditions are at higher risk due to prolonged exposure.
How to tell if you have this one
Look for yellow, capsule-shaped tablets with '343' debossed on one side and 'HH' on the other. The lot number is VSA000OV with an expiration date of February 2019.
- Brand
Pharma Pac- Category
Drug
What to do — step by step
Check Product Label
Identify the specific product by checking for yellow, capsule-shaped tablets with '343' and 'HH' debossed on the sides.
Questions people ask
Why is this product being recalled?
The recall is due to a carcinogen impurity detected in the API used to manufacture the Valsartan tablets.
What should I do if I have this product?
The official recall notice does not specify a remedy or action steps for affected consumers.
How can I tell if I have the recalled product?
Look for yellow, capsule-shaped tablets with '343' debossed on one side and 'HH' on the other, with lot number VSA000OV.
Contact Pharma Pac
We’ve drafted a message you can send Pharma Pac to request your refund or repair — edit it as you like.
Subject: Recall D-1022-2018 — Pharma Pac Pharma Pac Hello, I own a Pharma Pac that is covered by recall D-1022-2018 from Pharma Pac. 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-1022-2018 (July 26, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1022-2018 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.