Salsalate Tablets — Class II drug recall D-0166-2017
Terminated recall by Nationwide Laboratories, LLC, reported 2016-12-07, distributed nationwide. CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
| Recall number | D-0166-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nationwide Laboratories, LLC, Iselin, NJ, United States |
| Recall initiated | 2016-10-28 |
| Classified | 2016-12-01 |
| Reported by FDA | 2016-12-07 |
| Terminated | 2018-05-17 |
| Distributed | Nationwide (US) |
| Quantity | 2,514,500 tablets |
| Reason classes | potency, cgmp |
| NDC | 42937-0704-10, 42937-0704-18, 42937-0704-20 |
Product
Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-704-10); b) 500 count bottles (NDC 42937-704-18); and c) 1000 count bottles (NDC 42937-704-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.
Reason for recall
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
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-0166-2017. 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.