Olanzapine tablets — Class III drug recall D-0468-2017
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2017-02-15, distributed nationwide. Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Com
| Recall number | D-0468-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2016-10-13 |
| Classified | 2017-02-03 |
| Reported by FDA | 2017-02-15 |
| Terminated | 2017-07-24 |
| Distributed | Nationwide (US) |
| Quantity | 5,904 bottles |
| Reason classes | specification failure |
| NDC | 55111-0163, 55111-0163-01, 55111-0163-05, 55111-0163-30, 55111-0163-78, 55111-0163-79 |
Product
Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30
Reason for recall
Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
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-0468-2017. 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.