Unrated Drug recall · FDA · Published November 13, 2019

Precision Dose Ranitidine Oral Solution Recall: NDMA Impurity Risk

Precision Dose recalls ranitidine oral solution due to impurity N-nitrosodimethylamine (NDMA) found in the active pharmaceutical ingredient. This product is prescription-only and may pose health risks.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1004-2020Drug Precision Dose ›

Recall notice

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Precision Dose is recalling ranitidine oral solution (150 mg/10 mL) because it contains a harmful impurity called NDMA. This impurity could pose health risks, especially for people who take the medication regularly. Read more at govinfonow.com/recall/37699-precision-dose-ranitidine-oral-solution-recall-ndma-impurity-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/37699-precision-dose-ranitidine-oral-solution-recall-ndma-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1004-2020

Cite this page

“Precision Dose Ranitidine Oral Solution Recall: NDMA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37699-precision-dose-ranitidine-oral-solution-recall-ndma-impurity-risk. Based on FDA recall #D-1004-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1004-2020%22&limit=1).

The FDA announced on 2019-11-13 that Precision Dose Inc. voluntarily recalled Ranitidine Oral Solution due to CGMP deviations involving impurity N-nitrosodimethylamine (NDMA) found in the active pharmaceutical ingredient, according to FDA records.

How to tell if you have it

Brand: Precision Dose
Product: Ranitidine Oral Solution, USP, 150 mg/10 mL
NDC: 68094-204-62; 10 mL x 30 Unit Dose Cups per case
NDC: 68094-204-61; 10 mL x 100 Unit Dose Cups per case
Unit Dose Cup NDC: 68094-204-59
Lot number: 501290, Expiry: 11/30/19, NDC: 68094-204-61
Lot number: 501326, Expiry: 11/30/19, NDC: 68094-204-62
Lot number: 501501, Expiry: 11/30/19, NDC: 68094-204-62
Lot number: 1592, Expiry: 4/30/20, NDC: 68094-204-62
Lot number: 501679, Expiry: 4/30/20, NDC: 68094-204-61, 68094-204-62

The hazard

The recall addresses CGMP deviations where impurity N-nitrosodimethylamine (NDMA) was found in the API of Ranitidine Oral Solution, according to FDA records.

Context

GovInfoNow's records show Precision Dose Inc. has 6 other recalls on record since 2013-03-21. Other recent recalls of similar products include Precision Dose Glycopyrrolate Oral Solution Recall (2026-07-14), Precision Dose Acetaminophen Suspension Recall (2021-11-01), and Precision Dose Chlorhexidine Rinse Recall (2021-01-01). Other recent recalls of similar products include Novadoz Glycopyrrolate Oral Solution Recall (2025-12-15), Direct Rx DULOXETINE D/R 30mg Caps Recall (2026-06-22), and Cipla Cinacalcet Tablets Recall (2025-11-14).

How to tell if you have this one

Check the product label for the specific lot numbers: 501290, 501326, 501501, 1592, or 501679. The NDC codes listed are 68094-204-61, 68094-204-62, or 68094-204-59. This product is prescription-only and sold in unit dose cups.

Brand
Precision Dose
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the lot numbers 501290, 501326, 501501, 1592, or 501679 on the label.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.8 years after the firm started it.

Nov 13, 2019Firm started the recall
Mar 12, 2020FDA classified it Class II
Mar 18, 2020Published in FDA’s Enforcement Report
Sep 17, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/37699-precision-dose-ranitidine-oral-solution-recall-ndma-impurity-risk">Precision Dose Ranitidine Oral Solution Recall: NDMA Impurity Risk (GovInfoNow)</a>

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-1004-2020 (November 13, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1004-2020 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.