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Drug recall · FDA · Published January 1, 2021

Precision Dose Inc. recalls Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit Dose Cups (30-pack case) NDC 68094-028-61,

Precision Dose Inc. recalls 0.12% Chlorhexidine Gluconate Oral Rinse due to cGMP deviations. Products sold in 30-pack and 100-pack cases with specific lot numbers from 2021-2022.

🇺🇸 FDA recall #D-0228-2021DrugPrecision Dose ›
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Contact the company & request your remedy

Recalling firmPrecision Dose Inc.722 Progressive Ln, N/A · South Beloit, IL 61080-2616
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

Precision Dose Inc. is recalling 0.12% Chlorhexidine Gluconate Oral Rinse products that were made with cGMP deviations. This recall affects specific lot numbers of 30-pack and 100-pack cases sold between January 2021 and February 2022. Read more at govinfonow.com/recall/36559-precision-dose-chlorhexidine-rinse-recall-cgmp-deviations-in-0-12.

Source Summary by GovInfoNow · govinfonow.com/recall/36559-precision-dose-chlorhexidine-rinse-recall-cgmp-deviations-in-0-12 · Updated October 4, 2026 · FDA enforcement record: FDA #D-0228-2021

Cite this page

“Precision Dose Chlorhexidine Rinse Recall: Cgmp Deviations in 0.12% Oral Rinse.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36559-precision-dose-chlorhexidine-rinse-recall-cgmp-deviations-in-0-12. Based on FDA recall #D-0228-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0228-2021%22&limit=1).

Why it’s dangerous

The recall is due to cGMP deviations, which means the manufacturing process did not meet quality standards. This could potentially affect the safety and effectiveness of the product, but the exact risk is not specified in the recall notice.

Who’s affected

People who own or use the recalled Chlorhexidine Gluconate Oral Rinse products from Precision Dose Inc. in the US. Those with the specific lot numbers listed are most at risk.

How to tell if you have this one

Check for the product name 'Chlorhexidine Gluconate Oral Rinse USP 0.12%' in 30-pack or 100-pack cases. Look for the lot numbers listed in the recall: 502037, 502040, 502043, etc., with expiration dates from January 2021 to February 2022.

  • Brand
    Precision Dose
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the product by checking the lot number and expiration date on the packaging.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The recall is due to cGMP deviations, meaning the manufacturing process did not meet quality standards.

What should I do if I have this product?

The official notice does not specify a remedy, so check the product details and contact Precision Dose Inc. for further instructions.

Are there specific lot numbers I should avoid?

Yes, the recall includes specific lot numbers from 502037 to 502925 with expiration dates from January 2021 to February 2022.

Take action

Contact Precision Dose

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

Subject: Recall D-0228-2021 — Precision Dose Precision Dose

Hello,

I own a Precision Dose that is covered by recall D-0228-2021 from Precision Dose.

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-0228-2021 (January 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0228-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on October 4, 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