Olanzapine Tablets — Class III drug recall D-0702-2017
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-0702-2017 |
|---|---|
| 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 | 14,784 bottles |
| Reason classes | specification failure |
| NDC | 62756-0556-18, 62756-0556-83, 62756-0556-88 |
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 Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.
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-0702-2017. 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.