Direct Rx recalls Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC
Direct Rx recalls 300mg ranitidine tablets due to detected NDMA impurity. This chemical has been linked to potential health risks. Affected products were distributed with specific NDC and lot numbers.
Stop using this now
CGMP Deviations: Presence of NDMA impurity detected in product.
Contact the company & request your remedy
What happened, in plain English
Direct Rx is recalling ranitidine 300mg tablets because they contain NDMA impurity. This impurity has been linked to potential health risks, so affected products should be stopped use and disposed of safely. Read more at govinfonow.com/recall/37430-direct-rx-ranitidine-300mg-tablets-recall-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37430-direct-rx-ranitidine-300mg-tablets-recall-ndma-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0017-2021
Cite this page
“Direct Rx Ranitidine 300mg Tablets Recall: NDMA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37430-direct-rx-ranitidine-300mg-tablets-recall-ndma-impurity-risk. Based on FDA recall #D-0017-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0017-2021%22&limit=1).
Why it’s dangerous
NDMA is a chemical that has been found in some ranitidine products. It has been linked to potential health risks, including liver damage and other serious health issues. The presence of this impurity in the product makes it unsafe for use.
Who’s affected
People who have the specific ranitidine tablets with NDC 61919-455-30 and lot number 29JA1915 are affected. Those who have taken the product without medical supervision are at higher risk.
How to tell if you have this one
Check for ranitidine 300mg tablets with NDC code 61919-455-30 and lot number 29JA1915. These products were distributed by Direct Rx in Dawsonville, GA and expired by September 30, 2021.
- Brand
Direct Rx- Category
Drug
All 2 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
FL, GA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0016-2021 | Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534; Lots: a) 09AU1911 Exp. 02/28/2022; b) 09SE1904 Exp. 03/31/2022 | a) 54 bottles; b) 26 bottles |
| D-0017-2021 | Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30; Lot: 29JA1915 Exp. 09/30/2021 | 26 bottles |
What to do — step by step
Stop Using Now
Immediately stop using the recalled ranitidine tablets and dispose of them safely.
Questions people ask
Is this product safe to use?
No, the product contains NDMA impurity which has been linked to potential health risks. Do not use the recalled product.
What should I do with the recalled product?
Dispose of the product safely. Do not use it.
When was this product distributed?
The product was distributed by Direct Rx in Dawsonville, GA with specific NDC and lot numbers.
Contact Direct Rx
We’ve drafted a message you can send Direct Rx to request your refund or repair — edit it as you like.
Subject: Recall D-0017-2021 — Direct Rx Direct Rx Hello, I own a Direct Rx that is covered by recall D-0017-2021 from Direct Rx. 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-0017-2021 (January 15, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0017-2021 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.