The Recall Desk
ModerateFDA (Drugs)·D-0702-2017·Announced 2017-05-17

Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures

Sun Pharmaceutical Industries is recalling Olanzapine Tablets, 20 mg, because they failed impurity specifications. The recall covers 14,784 bottles distributed nationwide and in Puerto Rico.

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 III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The hazard is a minor labeling or specification error regarding impurities without reported illness.

Plain-English summary

Sun Pharmaceutical Industries, Inc. is recalling Olanzapine Tablets, 20 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 Industries Ltd. in India. A total of 14,784 bottles are involved in this recall. The specific lot numbers and expiration dates are: JKR5759A (Exp 04/18), JKP0943A (Exp 04/17), JKR5520A (Exp 04/18), and JKP0988A (Exp 04/17).

The product was distributed nationwide in the USA and Puerto Rico. Consumers and healthcare providers should check their inventory for these specific NDC numbers and lot numbers. If found, the product should be returned to the pharmacy or supplier for replacement or refund.

The recalled product

Product
Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88), and c) 1000-count bottles (NDC 62756-556-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuti
Manufacturer
Sun Pharmaceutical Industries, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
14,784

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 (6)

  • Lot #: a) JKR5759A
  • Exp 04/18
  • b) JKP0943A
  • Exp 04/17
  • JKR5520A
  • c) JKP0988A

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 →

Related recalls

Same manufacturer · Sun Pharmaceutical Industries, Inc.

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Same hazard · impurities

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