Bryant Ranch Prepack Inc. recalls Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles
Bryant Ranch Prepack Inc. recalls Valsartan 80 mg tablets due to detected carcinogen impurity in manufacturing. Affected lots include specific NDC numbers and expiration dates. Consumers should contact the manufacturer for details.
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
Bryant Ranch Prepack Inc. is recalling Valsartan 80 mg tablets because a carcinogen impurity was found in the drug product during manufacturing. This recall affects specific bottle sizes and lot numbers. The impurity poses a potential cancer risk if taken by patients. Read more at govinfonow.com/recall/39840-bryant-ranch-valsartan-tablets-recall-carcinogen-impurity-detected.
Source Summary by GovInfoNow · govinfonow.com/recall/39840-bryant-ranch-valsartan-tablets-recall-carcinogen-impurity-detected · Updated October 6, 2026 · FDA enforcement record: FDA #D-1027-2018
Cite this page
“Bryant Ranch Valsartan Tablets Recall: Carcinogen Impurity Detected.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39840-bryant-ranch-valsartan-tablets-recall-carcinogen-impurity-detected. Based on FDA recall #D-1027-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1027-2018%22&limit=1).
Why it’s dangerous
The recall is due to a carcinogen impurity detected in the active pharmaceutical ingredient used to make the drug. This impurity could potentially lead to cancer if the medication is taken by patients. The impurity was found during manufacturing quality control checks.
Who’s affected
Patients prescribed Valsartan 80 mg tablets by a healthcare provider are affected. Those with the specific bottle sizes and lot numbers listed in the recall are at risk of exposure to the carcinogen.
How to tell if you have this one
Check for Valsartan 80 mg tablets in 90-count, 60-count, or 28-count bottles with NDC numbers 63629-6922-2, 63629-6922-3, or 63629-6922-4. The lot number 111158 and expiration date of February 2019 are also associated with this recall.
- Brand
Bryant Ranch- Category
Drug
All 3 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
Product was distributed in HI, IN, and FL.
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-1027-2018 | Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-6922-4), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.; Lot # 111158; Exp. 02/19 | 690 tablets | — |
| D-1028-2018 | Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (NDC 6362-96905-3), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.; Lot # 114319; Exp. 10/18 Lot # 109004; Exp. 12/18 | 990 tablets | — |
| D-1029-2018 | Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.; Lot # 120879; Exp 10/19 | 90 tablets | 71335-0567-1, 71335-0567-2, 71335-0567-3, 71335-0567-4 |
What to do — step by step
Check Product Details
Identify the NDC number and expiration date on the product label to confirm if it matches the recalled items.
Questions people ask
Why is this medication being recalled?
The recall is due to a carcinogen impurity detected in the active pharmaceutical ingredient used to manufacture the drug.
What should I do if I have the recalled medication?
The recall record does not specify a remedy, so contact Bryant Ranch Prepack Inc. directly for guidance.
Is this recall affecting all Valsartan products?
No, only specific bottle sizes and lot numbers with NDC 63629-6922-2, 63629-6922-3, and 63629-6922-4 are affected.
Contact Bryant Ranch
We’ve drafted a message you can send Bryant Ranch to request your refund or repair — edit it as you like.
Subject: Recall D-1027-2018 — Bryant Ranch Bryant Ranch Hello, I own a Bryant Ranch that is covered by recall D-1027-2018 from Bryant Ranch. 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-1027-2018 (July 27, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1027-2018 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.