RANITIDINE SYRUP — Class III drug recall D-0162-2016
Terminated recall by Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals, reported 2015-11-11, distributed nationwide. Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
| Recall number | D-0162-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals, Huntsville, AL, United States |
| Recall initiated | 2015-10-21 |
| Classified | 2015-11-02 |
| Reported by FDA | 2015-11-11 |
| Terminated | 2016-10-23 |
| Distributed | Nationwide (US) |
| Quantity | 61,146 bottles |
| Reason classes | specification failure |
| NDC | 00603-9418-58 |
| Lot numbers | 12/15, 5/16, L023F14A, L024F14A, L088L13A |
Product
RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58.
Reason for recall
Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.
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-0162-2016. 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.