Ranitidine Syrup — Class II drug recall D-829-2013
Terminated recall by Actavis South Atlantic LLC, reported 2013-08-07, distributed nationwide. Failed Impurity/Degradation Specification; "Related Compound C"
| Recall number | D-829-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Actavis South Atlantic LLC, Sunrise, FL, United States |
| Recall initiated | 2013-05-15 |
| Classified | 2013-07-30 |
| Reported by FDA | 2013-08-07 |
| Terminated | 2014-05-15 |
| Distributed | Nationwide (US) |
| Quantity | 133,968 bottles |
| Reason classes | specification failure |
| Lot numbers | 247900, 251000, 256000, 261200, 263600, 266700, 277100, 280300, 284300 |
Product
Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28092 USA
Reason for recall
Failed Impurity/Degradation Specification; "Related Compound C"
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-829-2013. 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.