Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Lamotrigine Tablets Recalled by Mylan Pharmaceuticals Inc. Due to CGMP Deviations: Pharmaceuticals were produced and distributed with...
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 Mylan Pharmaceuticals Inc. directly.
Affected Products
Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b) 500-count bottles (NDC 0378-4254-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.
Quantity: 28,140 bottles
Why Was This Recalled?
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mylan Pharmaceuticals Inc.
Mylan Pharmaceuticals Inc. has 71 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report