Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Orphenadrine Citrate Extended-Release Tablets Recalled by Sandoz, Inc Due to CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily...
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, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.
Quantity: 7908 bottles(790,800 extended release tablets)
Why Was This Recalled?
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sandoz, Inc
Sandoz, Inc has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report