Orphenadrine Citrate Extended Release Tablets (Sandoz) – Dissolution 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
Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540.
Brand
Sandoz Inc
Lot Codes / Batch Numbers
Lot # DM1316, Exp. 05/16 Lot # DM1318, Exp. 05/16
Products Sold
Lot # DM1316; Exp. 05/16 Lot # DM1318; Exp. 05/16
Sandoz Inc is recalling Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 10 due to Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.. 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 Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
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