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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

A-S Medication Solutions LLC.: Valsartan Tablets Recalled for Carcinogen Impurity Contamination

Agency Publication Date: August 18, 2018
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Summary

Approximately 1,899 bottles of Valsartan and Valsartan with Hydrochlorothiazide (HCTZ) are being recalled because a carcinogen impurity was detected in the active ingredient used to manufacture these blood pressure medications. The recall involves various bottle sizes and strengths, including 80 mg, 160 mg, and 320 mg tablets distributed nationwide. Consumers using these medications should contact their doctor or pharmacist immediately, as the presence of this impurity may pose a long-term health risk. No specific injuries have been reported in this notice, but the firm initiated the recall due to deviations from manufacturing quality standards.

Risk

The medication contains an impurity classified as a carcinogen, which is a substance that could potentially cause cancer with long-term exposure. This impurity was found in the Active Pharmaceutical Ingredient (API) provided by overseas suppliers during the manufacturing process.

What You Should Do

  1. Check your prescription bottle for the following NDC numbers: 54569-6583-0, 54569-6583-1 (160 MG), 54569-6582-0, 54569-6582-1 (80 MG), 54569-6480-0 (160/12.5 MG), or 54569-6488-0 (320/25 MG).
  2. Verify your lot number and expiration date against the affected list, which includes lots such as 7285177 (Exp 2/28/2019), 7258177 (Exp 11/30/2018), 8033130 (Exp 4/30/2019), and 7293219 (Exp 1/31/2019).
  3. Do not stop taking your medication without first consulting your healthcare provider or pharmacist, as the risk of stopping blood pressure medication suddenly may outweigh the risk of the impurity.
  4. Contact your healthcare provider or pharmacist for guidance and to obtain a replacement prescription or alternative treatment.
  5. Return any unused portion of the recalled medication to your pharmacy for a refund and contact A-S Medication Solutions LLC. for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Valsartan Tablets, 160 MG, 30-count bottle
Model:
NDC 54569-6583-0
Recall #: D-1108-2018
Lot Numbers:
7285177 (Exp 2/28/2019)
7222163 (Exp 3/31/2019)
7227175 (Exp 3/31/2019)
8162190 (Exp 8/31/2019)
8183227 (Exp 8/31/2019)
Date Ranges: February 28, 2019, March 31, 2019, August 31, 2019
Product: Valsartan Tablets, 160 MG, 90-count bottle
Model:
NDC 54569-6583-1
Recall #: D-1108-2018
Lot Numbers:
7207135 (Exp 2/28/2019)
7212280 (Exp 2/28/2019)
7215073 (Exp 2/28/2019)
7222162 (Exp 3/31/2019)
8095248 (Exp 8/31/2019)
8095249 (Exp 8/31/2019)
Date Ranges: February 28, 2019, March 31, 2019, August 31, 2019
Product: Valsartan Tablets, 80 MG, 30-count bottle
Model:
NDC 54569-6582-0
Recall #: D-1109-2018
Lot Numbers:
7258177 (Exp 11/30/2018)
7276228 (Exp 11/30/2018)
7212260 (Exp 2/28/2019)
Date Ranges: November 30, 2018, February 28, 2019
Product: Valsartan Tablets, 80 MG, 90-count bottle
Model:
NDC 54569-6582-1
Recall #: D-1109-2018
Lot Numbers:
7208140 (Exp 11/30/2018)
7212261 (Exp 2/28/2019)
7221155 (Exp 2/28/2019)
7222161 (Exp 2/28/2019)
8109171 (Exp 8/31/2019)
8109170 (Exp 9/30/2019)
Date Ranges: November 30, 2018, February 28, 2019, August 31, 2019, September 30, 2019
Product: Valsartan and Hydrochlorothiazide Tablets, 160 MG / 12.5 MG, 90-count
Model:
NDC 54569-6480-0
Recall #: D-1110-2018
Lot Numbers:
8033130 (Exp 4/30/2019)
8068192 (Exp 7/31/2019)
8110183 (Exp 7/31/2019)
8080157 (Exp 7/31/2019)
8190195 (Exp 7/31/2019)
Date Ranges: April 30, 2019, July 31, 2019
Product: Valsartan and Hydrochlorothiazide Tablets, 320 MG / 25 MG, 90-count
Model:
NDC 54569-6488-0
Recall #: D-1111-2018
Lot Numbers:
7293219 (Exp 1/31/2019)
7362231 (Exp 6/30/2019)
8074161 (Exp 6/30/2019)
8110184 (Exp 6/30/2019)
8197215 (Exp 6/30/2019)
8114178 (Exp 6/30/2019)
8115123 (Exp 6/30/2019)
7132187 (Exp 9/30/2018)
7160161 (Exp 9/30/2018)
7180150 (Exp 9/30/2018)
7268239 (Exp 9/30/2018)
Date Ranges: September 30, 2018, January 31, 2019, June 30, 2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80748
Status: Active
Manufacturer: A-S Medication Solutions LLC.
Sold By: Pharmacies
Manufactured In: China, Malta, United States
Units Affected: 4 products (666 bottles; 178 bottles; 524 bottles; 531 bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.