FDA Drug recall D-1314-2020
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurol…
- FDA Drug
- Class III
- terminated
- Published 2020-06-24
On 2020-06-24 the FDA classified a Class III recall of Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurol… by Aurobindo Pharma Usa, citing failed Impurities/ Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1314-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-05-26 |
| Published | 2020-06-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aurobindo Pharma Usa |
| Distribution | US |
Product
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30
Reason
Failed Impurities/ Degradation Specifications
Identifiers
| code_info | Lot #: 561180046A1, Exp 8/2020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class II · 2025-06-25 · Aurobindo Pharma Usa - Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Wind…
FDA Drug · Class II · 2024-12-25 · Aurobindo Pharma Usa - Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, D…
FDA Drug · Class II · 2024-12-11 · Aurobindo Pharma Usa - Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Di…
FDA Drug · Class II · 2024-12-11 · Aurobindo Pharma Usa
All Aurobindo Pharma Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1314-2020%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.