SDA Senna Syrup — Class II drug recall D-0851-2018
Terminated recall by RIJ Pharmaceutical LLC, reported 2018-06-20, distributed nationwide. CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a
| Recall number | D-0851-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RIJ Pharmaceutical LLC, Middletown, NY, United States |
| Recall initiated | 2018-05-07 |
| Classified | 2018-06-08 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2023-04-07 |
| Distributed | Nationwide (US) |
| Quantity | 3,537 bottles |
| Reason classes | microbial contamination, cgmp, specification failure |
| UPC / GTIN / UDI-DI | 00366424562082 |
| NDC | 66424-0562, 66424-0562-08 |
| Lot numbers | 09/18, 47070042 |
Product
SDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, Distributed by SDA Laboratories 280 Railroad Avenue, Greenwich CT 06830, NDC 66424-562-08, UPC 366424562082
Reason for recall
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
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-0851-2018. 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.