Quetiapine Fumarate Tablets (Dr. Reddy's) – Dissolution Failure (2012)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
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
Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05
Brand
Dr. Reddy's Laboratories, Inc.
Lot Codes / Batch Numbers
Lot C203090 Exp.03/14
Products Sold
Lot C203090 Exp.03/14
Dr. Reddy's Laboratories, Inc. is recalling Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laborato due to Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fu. 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 USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
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 7, 2026