Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Orphenadrine Citrate Extended Release Tablets Recalled by Sandoz Inc Due to Failed Dissolution Specifications: Product found to be out...

Date: July 11, 2014
Company: Sandoz Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Sandoz Inc directly.

Affected Products

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.

Quantity: 781,000 extended release tablets

Why Was This Recalled?

Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Sandoz Inc

Sandoz Inc has 30 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report