The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0701-2017·Announced 2017-05-17

Sun Pharmaceutical Recalls Olanzapine Tablets Due to Impurity Failures

Sun Pharmaceutical Industries is recalling Olanzapine Tablets, 10 mg, because they failed impurity specifications. The recall covers 38,316 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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences. The source text does not report any illnesses or injuries.

Plain-English summary

Sun Pharmaceutical Industries, Inc. is recalling Olanzapine Tablets, 10 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 38,316 bottles were distributed nationwide in the USA and in Puerto Rico. Specific lot numbers and expiration dates are listed in the recall details.

Consumers who have this medication should stop using it and contact their healthcare provider or pharmacist for guidance on how to dispose of the product or obtain a replacement.

The recalled product

Product
Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count bottles (NDC 62756-554-18), 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
38,316

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 (13)

  • Lot #: a) JKP1354A
  • Exp 03/17
  • JKP2746A
  • Exp 06/17
  • JKR5751A
  • Exp 04/18
  • b) JKP1355A
  • JKP2738A
  • JKP3145A
  • JKR5476A
  • c) JKP1353A
  • JKP3146A
  • JKP2746B

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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