Carisoprodol Tablets (Mylan) – Impurity Specification Failure (2014)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
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
Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL NDC 51079-819-20
Brand
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Lot Codes / Batch Numbers
Lots and Expiration Dates: 3037463, Expires 2/2014, 3039466, Expires 3/2014, 3040644, Expires 4/2014, 3043463, Expires 6/2014, 3049568, Expires 3/2015
Products Sold
Lots and Expiration Dates: 3037463, Expires 2/2014; 3039466, Expires 3/2014; 3040644, Expires 4/2014; 3043463, Expires 6/2014; 3049568, Expires 3/2015
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) is recalling Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets due to Failed Impurity/degradation Specification. 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
Failed Impurity/degradation Specification
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 10, 2026