Lannett Company, Inc. recalls Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc.
Lannett Company recalls ranitidine syrup due to detected NDMA impurity. This may pose health risks. Check your product's NDC codes for affected batches.
Recall notice
CGMP Deviations: Presence of NDMA impurity detected in product.
Contact the company & request your remedy
What happened, in plain English
Lannett Company is recalling ranitidine syrup (Ranitidine Oral Solution) because it contains NDMA impurities. This impurity has been linked to potential health risks, so affected products should be stopped and disposed of. Read more at govinfonow.com/recall/37776-lannett-ranitidine-syrup-recall-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37776-lannett-ranitidine-syrup-recall-ndma-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0309-2020
Cite this page
“Lannett Ranitidine Syrup Recall: NDMA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37776-lannett-ranitidine-syrup-recall-ndma-impurity-risk. Based on FDA recall #D-0309-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0309-2020%22&limit=1).
Why it’s dangerous
NDMA is a potential carcinogen that can form in some medications during manufacturing. The presence of this impurity in ranitidine syrup may pose health risks, though the exact risk level is not fully specified in the recall notice.
Who’s affected
People who have the recalled ranitidine syrup (15mg/mL prescription-only) are affected. Those with medical conditions requiring this medication are at higher risk.
How to tell if you have this one
Check for NDC codes 54838-550-80 through 2216A (as listed in the recall notice). The product was distributed by Lannett Company, Inc. in the United States starting in 2019.
- Brand
Lannett- Category
Drug
What to do — step by step
Stop Using Product
Immediately stop using the recalled ranitidine syrup if you have it.
Questions people ask
Is this product safe to use?
The recall notice states that NDMA impurities were detected, but does not specify if the product is safe to use. Affected products should be stopped and disposed of.
What NDC codes are affected?
The affected NDC codes range from 54838-550-80 to 2216A as listed in the recall notice.
How can I check if my product is recalled?
Check the NDC codes on your product label. The affected codes are listed in the recall notice from 54838-550-80 through 2216A.
Contact Lannett
We’ve drafted a message you can send Lannett to request your refund or repair — edit it as you like.
Subject: Recall D-0309-2020 — Lannett Lannett Hello, I own a Lannett that is covered by recall D-0309-2020 from Lannett. 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-0309-2020 (October 28, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0309-2020 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.