Salsalate Tablets 750mg (Nationwide Laboratories) – CGMP Manufacturing Risk (2016)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Nationwide Laboratories, LLC
Lot Codes / Batch Numbers
Lot #: a) 28141502, 28141503, 28141504, 28141505, 28141506, Exp 03/17, 28141507, Exp 09/17, 28141508, 28141510, 28141511, Exp 10/17, b) 28141502, 28141504, 28141506, Exp 03/17, 28141507, Exp 09/17, 28141508, 28141510, 28141511, Exp 10/17, c) 28141501, 28141502, 28141504, 28141506, Exp 03/17, 28141507, Exp 09/17, 28141508, 28141510, 28141511, Exp 10/17
Products Sold
Lot #: a) 28141502, 28141503, 28141504, 28141505, 28141506, Exp 03/17; 28141507, Exp 09/17; 28141508, 28141510, 28141511, Exp 10/17; b) 28141502, 28141504, 28141506, Exp 03/17; 28141507, Exp 09/17; 28141508, 28141510, 28141511, Exp 10/17; c) 28141501, 28141502, 28141504, 28141506, Exp 03/17; 28141507, Exp 09/17; 28141508, 28141510, 28141511, Exp 10/17
Nationwide Laboratories, LLC is recalling Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-704-10); b) 500 count bo due to CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026