CLASS II Drug recall · Reported 7 Aug 2013 · FDA Enforcement Report
Olanzapine Tablets, USP, 10 mg recalled by Torrent Pharma
Torrent Pharma is recalling Olanzapine Tablets, USP, 10 mg, distributed nationwide in the US. The recall was initiated on 22 Jul 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-830-2013
- FDA event ID
- 65780
- Recalling firm
- Torrent Pharma, Kalamazoo, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Jul 2013
- FDA classified
- 1 Aug 2013
- Reported
- 7 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 22 Jul 2013 | Recall initiated by company | |
| 1 Aug 2013 | Classified by FDA | +10 days |
| 7 Aug 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot #: BS392004A, Exp: 09/2014
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Torrent Pharma
All 84| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fluoxetine Tablets, USP, 20 mg recalled by Torrent PharmaFluoxetine | Torrent Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Fluoxetine Tablets, USP, 20 mg Carton ( Unit-dose) recalledFluoxetine | Torrent Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg recalledPantoprazole Sodium | Torrent Pharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Carbamazepine Tablets, USP 200 mg recalled by Torrent PharmaCarbamazepine | Torrent Pharma | Potency & Assay | Nationwide |
| Drug | CLASS III | Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg recalled | Torrent Pharma | Potency & Assay | Nationwide |
Other Olanzapine recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Olanzapine Tablets, USP 5 mg recalled by Macleods PharmaceuticalsOlanzapine | Macleods Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Olanzapine Tablets, USP 2.5 mg recalled by Macleods PharmaceuticalsOlanzapine | Macleods Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Olanzapine Tablets, USP 10 mg recalled by Macleods Pharma UsaOlanzapine | Macleods Pharma Usa | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Olanzapine Tablets, USP 2.5 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Olanzapine Tablets, USP 7.5 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Potency & Assay | Nationwide |