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Drug recall · FDA · Published November 4, 2019

Teva Pharmaceuticals USA, Inc. recalls Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only, Manufactured for:

Teva Pharmaceuticals recalls Valganc: 50 mg/mL oral solution with brown/black particles detected during testing. This medication is prescription-only and may be unsafe for patients.

🇺🇸 FDA recall #D-0518-2020DrugTeva Pharmaceuticals ›
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Contact the company & request your remedy

Recalling firmTeva Pharmaceuticals USA, Inc.1090 Horsham Rd, N/A · North Wales, PA 19454-1505
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
✎ GovInfoNow plain-language explainer

What happened, in plain English

Teva Pharmaceuticals is recalling a specific prescription valganciclovir oral solution due to brown/black particles found during stability testing. This could pose a risk of injury if the particles enter the mouth or throat during use. Read more at govinfonow.com/recall/37768-teva-valganciclovir-oral-solution-recall-brown-black-particles-found.

Source Summary by GovInfoNow · govinfonow.com/recall/37768-teva-valganciclovir-oral-solution-recall-brown-black-particles-found · Updated October 5, 2026 · FDA enforcement record: FDA #D-0518-2020

Cite this page

“Teva Valganciclovir Oral Solution Recall: Brown/black particles found.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37768-teva-valganciclovir-oral-solution-recall-brown-black-particles-found. Based on FDA recall #D-0518-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0518-2020%22&limit=1).

Why it’s dangerous

The stability testing detected brown or black particles in the medication. These particles could potentially cause injury if they enter the mouth or throat during use, though the risk is low and not life-threatening.

Who’s affected

Prescription patients using the specific Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL bottle. Those with the lot numbers CBFCN or CBHFG from May 2020 are most at risk.

How to tell if you have this one

Check for the 100 mL (3.4 fl. oz.) bottle labeled 'Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL'. Look for lot numbers CBFCN or CBHFG from May 2020.

  • Brand
    Teva Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the product by checking the bottle size (100 mL), concentration (50 mg/mL), and lot numbers CBFCN or CBHFG from May 2020.

✎ GovInfoNow

Questions people ask

Is this medication safe to use?

The recall states brown/black particles were found during testing, but the product is still safe to use if the particles do not enter the mouth or throat.

What should I do if I have this product?

The recall does not specify a remedy, so contact your healthcare provider for guidance on whether to continue using the product.

How can I tell if I have the recalled product?

Check for the 100 mL bottle with lot numbers CBFCN or CBHFG from May 2020.

Take action

Contact Teva Pharmaceuticals

We’ve drafted a message you can send Teva Pharmaceuticals to request your refund or repair — edit it as you like.

Subject: Recall D-0518-2020 — Teva Pharmaceuticals Teva Pharmaceuticals

Hello,

I own a Teva Pharmaceuticals that is covered by recall D-0518-2020 from Teva 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-0518-2020 (November 4, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0518-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA