Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL
Medicine recall D-0309-2020. Published in FDA’s Enforcement Report on Nov 20, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 20, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 683,149 bottles how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
CGMP Deviations: Presence of NDMA impurity detected in product.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 NDC 54838-550-80
683,149 bottles, in FDA’s words.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
1503A 10/2019 1504A 10/2019 1505A 10/2019 1523A 10/2019 1524A 10/2019 1525A 11/2019 1561A 12/2019 1562A 12/2019 1563A 12/2019 1589A 12/2019 1590A 12/2019 1591A 12/2019 1614A 01/2020 1615A 01/2020 1617A 01/2020 1644A 02/2020 1775A 06/2020…
Every code shown here, 1,259 characters
1503A 10/2019 1504A 10/2019 1505A 10/2019 1523A 10/2019 1524A 10/2019 1525A 11/2019 1561A 12/2019 1562A 12/2019 1563A 12/2019 1589A 12/2019 1590A 12/2019 1591A 12/2019 1614A 01/2020 1615A 01/2020 1617A 01/2020 1644A 02/2020 1775A 06/2020 1646A 02/2020 1647A 02/2020 1668A 03/2020 1669A 03/2020 1670A 03/2020 1708A 03/2020 1709A 04/2020 1710A 04/2020 1729A 04/2020 1730A 04/2020 1731A 04/2020 1757A 05/2020 1758A 05/2020 1759A 05/2020 1773A 06/2020 1774A 06/2020 1989A 12/2020 1794A 06/2020 1795A 06/2020 1796A 06/2020 1817A 06/2020 1818A 07/2020 1819A 07/2020 1840A 08/2020 1840B 08/2020 1841A 08/2020 1842A 08/2020 1863A 08/2020 1864A 09/2020 1865A 09/2020 1899A 10/2020 1900A 10/2020 1901A 10/2020 1910A 10/2020 1911A 10/2020 1912A 10/2020 1918A 10/2020 1919A 10/2020 1920A 10/2020 1925A 10/2020 1926A 10/2020 1927A 10/2020 1977A 12/2020 1978A 12/2020 1979A 12/2020 1990A 12/2020 1991A 12/2020 1998A 01/2021 1999A 01/2021 2000A 01/2021 2019A 01/2021 2020A 01/2021 2065A 03/2021 2066A 03/2021 2067A 03/2021 2071A 03/2021 2072A 03/2021 2073A 03/2021 2076A 03/2021 2077A 03/2021 2078A 03/2021 2126A 05/2021 2127A 05/2021 2128A 05/2021 2164A 06/2021 2165A 06/2021 2166A 06/2021 2179A 06/2021 2180A 07/2021 2181A 07/2021 2214A 08/2021 2215A 08/2021 2216A 08/2021
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Barcodes and drug codes
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NDC
54838-550-80
As FDA’s description and codes give them; the UPCs written as digits only.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 28, 2019.
- FDA classified it on Nov 10, 2019.
- FDA’s Enforcement Report published it on Nov 20, 2019.
- FDA terminated it on Apr 26, 2021.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Lannett Company, Inc., of Philadelphia, PA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Press Release.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Drug recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.