Olanzapine Tablets — Class III drug recall D-1315-2020
Terminated recall by Aurobindo Pharma USA Inc., reported 2020-06-24, distributed nationwide. Failed Impurities/ Degradation Specifications
| Recall number | D-1315-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma USA Inc., East Windsor, NJ, United States |
| Recall initiated | 2020-05-26 |
| Classified | 2020-06-17 |
| Reported by FDA | 2020-06-24 |
| Terminated | 2023-01-10 |
| Distributed | Nationwide (US) |
| Quantity | 7,547 bottles |
| Reason classes | specification failure |
| NDC | 66993-0682-30 |
| Lot numbers | 563180012A1 |
| Expiration dates | 2020-08 |
Product
Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-682-30
Reason for recall
Failed Impurities/ Degradation Specifications
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-1315-2020. 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.