FDA Drug recall D-0701-2017
Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count b…
- FDA Drug
- Class III
- terminated
- Published 2017-05-17
On 2017-05-17 the FDA classified a Class III recall of Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count b… by Sun Pharmaceutical Industries, citing failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0701-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-03-22 |
| Published | 2017-05-17 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count bottles (NDC 62756-554-18), 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, NDC 62756-551-18.
Reason
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Identifiers
| code_info | Lot #: a) JKP1354A, Exp 03/17, JKP2746A, Exp 06/17, JKR5751A, Exp 04/18; b) JKP1355A, Exp 03/17, JKP2738A, JKP3145A, Ex…Lot #: a) JKP1354A, Exp 03/17, JKP2746A, Exp 06/17, JKR5751A, Exp 04/18; b) JKP1355A, Exp 03/17, JKP2738A, JKP3145A, Exp 06/17, JKR5476A, Exp 04/18; c) JKP1353A, Exp 03/17, JKP3146A, JKP2746B, Exp 06/17 |
|---|
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-0701-2017%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.