Class III · Lower riskRecall completed
Olanzapine Tablets
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot #: 561180046A1, Exp 8/2020
Where it was soldU.S.A. Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Impurities/ Degradation Specifications
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byAurolife Pharma LLC Dayton, NJ 08810
| Distributed by / for | Prasco Laboratories Mason, OH 45040 USA |
| NDC | 66993-680-30 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | Aurobindo Pharma USA Inc. |
| Distribution | U.S.A. Nationwide |
| Quantity | 13322 bottles |
| Recall initiated | 2020-05-26 |
| Report date | 2020-06-24 |
| Recall completed | 2023-01-10 |
| Recall number | D-1314-2020 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | East Windsor NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.