Olanzapine Tablets (Torrent) – Defective Container (2013)
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
Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Prasco Laboratories, Mason OH, 45040, USA, Mfd by: Torrent Pharmaceuticals Ltd., Indrad-382 721, Dist. Mehsana India, NDC 66993-463-30
Brand
Torrent Pharma Inc
Lot Codes / Batch Numbers
Lot #: BS392004A, Exp: 09/2014
Products Sold
Lot #: BS392004A, Exp: 09/2014
Torrent Pharma Inc is recalling Olanzapine Tablets, USP, 10 mg, Rx Only, 30 tablets per bottle, Mfd for: Prasco Laboratories, Mason due to Defective Container; This action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material th. 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
Defective Container; This action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material that (removes or blocks) less moisture than what is approved in the application.
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 10, 2026