FDA Drug recall D-0468-2017
Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC…
- FDA Drug
- Class III
- terminated
- Published 2017-02-15
On 2017-02-15 the FDA classified a Class III recall of Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC… by Dr Reddy S Laboratories, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0468-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-10-13 |
| Published | 2017-02-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
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
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.
Identifiers
| ndc | 55111-163-30 |
|---|---|
| ndc | 55111-163-01 |
| ndc | 55111-163-05 |
| ndc | 55111-163-79 |
| ndc | 55111-163-78 |
| code_info | C500202 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0468-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.