Torrent Pharma Recalls Olanzapine Tablets Due to Defective Container
Torrent Pharma Inc is recalling 18,721 bottles of Olanzapine Tablets 10 mg because the packaging filler material was not approved.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and is described as a precautionary measure due to a packaging defect, which aligns with the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Torrent Pharma Inc is recalling 18,721 bottles of Olanzapine Tablets, USP, 10 mg, Rx Only. The affected product is identified by Lot # BS392004A with an expiration date of 09/2014. The product was distributed nationwide.
The recall is a precautionary measure due to a defective container. The product was re-packaged in the U.S. using a filler material that removes or blocks less moisture than what is approved in the application.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance.
The recalled product
- 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
- Manufacturer
- Torrent Pharma Inc
- Category
- Drug — Prescription Medication
- Affected units
- 18,721
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: BS392004A
- Exp: 09/2014
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Torrent Pharma Inc
See all →- HighFluoxetine Tablets USP 20 mg Recalled for N-Nitroso Contamination
FDA (Drugs) · 2025-06-11
- SevereFluoxetine Tablets 20 mg Recalled for N-Nitroso Impurity
FDA (Drugs) · 2025-06-11
- High
- ModerateCarbamazepine tablets recalled for failed dissolution specifications
FDA (Drugs) · 2022-01-19
- ModerateTelmisartan and Hydrochlorothiazide Tablets Recalled for Superpotency
FDA (Drugs) · 2021-12-22
Same hazard · packaging defect
See all →- HighMD Wipe Outz Numbing Tattoo Wipes Recalled for Child Poisoning Risk
CPSC · 2026-08-27
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- SevereDermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighBiopsy Forceps Recall: Sterile Packaging Breach Risk
FDA (Devices) · 2026-08-12