The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0700-2017·Announced 2017-05-17

Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures

Sun Pharmaceutical Industries is recalling Olanzapine Tablets, 7.5 mg, because they failed impurity specifications. The recall covers 6,138 bottles distributed nationwide and in Puerto Rico.

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 the rubric defines as unlikely to cause adverse health consequences, typically corresponding to a score of 1 or 2. The hazard involves impurities without reported illness, fitting the 'Moderate' category for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Sun Pharmaceutical Industries, Inc. is recalling Olanzapine Tablets, 7.5 mg, in 30-count, 100-count, and 1000-count bottles. The recall is due to out-of-specification results for the related substances test parameter, which indicates the presence of impurities.

The affected product is distributed by Sun Pharmaceutical Industries, Inc., in Cranbury, NJ, and manufactured by Sun Pharmaceutical Ind. Ltd. in India. A total of 6,138 bottles are involved in this recall. The specific lot numbers and expiration dates are listed in the structured product information provided by the agency.

The recall is distributed nationwide in the USA and Puerto Rico. Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88), and c) 1000-count bottles (NDC 62756-553-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun…
Manufacturer
Sun Pharmaceutical Industries, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
6,138

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 (11)

  • Lot #: a) JKP3150B
  • Exp 06/17
  • JKR5749A
  • Exp 06/18
  • b) JKP2757A
  • Exp 05/17
  • JKP3149A
  • JKP3150A
  • JKR5049A
  • Exp 04/18
  • c) JKP2758B

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 4 products in this recall →

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