Olanzapine Tablets — Class II drug recall D-830-2013
Terminated recall by Torrent Pharma Inc, reported 2013-08-07, distributed nationwide. Defective Container; This action is being taken as a precautionary measure due to the product being re-package
| Recall number | D-830-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Torrent Pharma Inc, Kalamazoo, MI, United States |
| Recall initiated | 2013-07-22 |
| Classified | 2013-08-01 |
| Reported by FDA | 2013-08-07 |
| Terminated | 2014-01-31 |
| Distributed | Nationwide (US) |
| Quantity | 18,721 bottles |
| Reason classes | packaging |
| NDC | 66993-0463-30 |
| Lot numbers | BS392004A |
| Expiration dates | 2014-09 |
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-830-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.