Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Quetiapine Fumarate Extended-Release Tablets Recalled by The Harvard Drug Group Due to Labeling; Incorrect or Missing Package Insert: Product was...
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 The Harvard Drug Group directly.
Affected Products
Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC: 0904-6803-61
Quantity: 115 cartons
Why Was This Recalled?
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About The Harvard Drug Group
The Harvard Drug Group has 45 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report