Lannett Ranitidine Syrup — Class II drug recall D-0309-2020
Terminated recall by Lannett Company, Inc., reported 2019-11-20, distributed nationwide. CGMP Deviations: Presence of NDMA impurity detected in product.
| Recall number | D-0309-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lannett Company, Inc., Philadelphia, PA, United States |
| Recall initiated | 2019-10-28 |
| Classified | 2019-11-10 |
| Reported by FDA | 2019-11-20 |
| Terminated | 2021-04-26 |
| Distributed | Nationwide (US) |
| Quantity | 683,149 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 54838-0550-80 |
Product
Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 NDC 54838-550-80
Reason for recall
CGMP Deviations: Presence of NDMA impurity detected in product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0309-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.