Olanzapine Tablets — Class III drug recall D-0699-2017
Terminated recall by Sun Pharmaceutical Industries, Inc., reported 2017-05-17, distributed nationwide. Failed Impurities/Degradation Specifications: out of specification results for the related substances test par
| Recall number | D-0699-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sun Pharmaceutical Industries, Inc., Cranbury, NJ, United States |
| Recall initiated | 2017-03-22 |
| Classified | 2017-05-10 |
| Reported by FDA | 2017-05-17 |
| Terminated | 2018-07-11 |
| Distributed | Nationwide (US) |
| Quantity | 60 bottles |
| Reason classes | specification failure |
| NDC | 62756-0551-18 |
| Lot numbers | 04/18, 05/17, JKP2751A, JKR5048A |
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.
Reason for recall
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0699-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.