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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76819

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 22, 2017
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Sun Pharmaceutical Industries, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 4

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.

D-0699-2017
Recall number
D-0699-2017
Initiated
March 22, 2017
Classification
Class III
Status
Terminated
Quantity
60 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).

Code information

Lot #: JKP2751A, Exp 05/17; JKR5048A, Exp 04/18

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 2 of 4

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 Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.

D-0700-2017
Recall number
D-0700-2017
Initiated
March 22, 2017
Classification
Class III
Status
Terminated
Quantity
6,138 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).

Code information

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

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 3 of 4

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 Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India, NDC 62756-551-18.

D-0701-2017
Recall number
D-0701-2017
Initiated
March 22, 2017
Classification
Class III
Status
Terminated
Quantity
38,316 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).

Code information

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

Distribution pattern

Nationwide in the USA and Puerto Rico

drug · product 4 of 4

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 Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.

D-0702-2017
Recall number
D-0702-2017
Initiated
March 22, 2017
Classification
Class III
Status
Terminated
Quantity
14,784 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).

Code information

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

Distribution pattern

Nationwide in the USA and Puerto Rico