Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures
Sun Pharmaceutical Industries is recalling specific lots of Olanzapine Tablets, 2.5 mg, because they failed impurity specifications.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 III, which is defined as unlikely to cause adverse health consequences. The issue is a failure in impurity specifications without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling 60 bottles of Olanzapine Tablets, 2.5 mg, 1000-count bottles. The affected products are distributed nationwide in the USA and Puerto Rico. The specific lots involved are JKP2751A (Exp 05/17) and JKR5048A (Exp 04/18).
The recall was initiated because the products failed impurities/degradation specifications, specifically showing out-of-specification results for the related substances test parameter. This indicates the presence of impurities that did not meet the required quality standards.
Consumers who have these specific lots of Olanzapine Tablets should stop using them and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative medication.
The recalled product
- Product
- Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-551-18.
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 60
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 (4)
- Lot #: JKP2751A
- Exp 05/17
- JKR5048A
- Exp 04/18
Distribution
Part of a larger recall action
This product is one of 4 recalled by Sun Pharmaceutical Industries, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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