CLASS III Drug recall · Reported 24 Jun 2020 · FDA Enforcement Report
Olanzapine Tablets, USP 2.5 mg recalled by Aurobindo Pharma USA
Aurobindo Pharma USA is recalling Olanzapine Tablets, USP 2.5 mg, distributed nationwide in the US. The recall was initiated on 26 May 2020 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1314-2020
- FDA event ID
- 85756
- Recalling firm
- Aurobindo Pharma USA, East Windsor, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 26 May 2020
- FDA classified
- 17 Jun 2020
- Reported
- 24 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 26 May 2020 | Recall initiated by company | |
| 17 Jun 2020 | Classified by FDA | +22 days |
| 24 Jun 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/ Degradation Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/ Degradation Specifications
Which lots are affected?
Lot #: 561180046A1, Exp 8/2020
Where was it sold?
U.S.A. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 85756This product is part of a recall event; the main page for the event is Olanzapine Tablets, USP 7.5 mg recalled by Aurobindo Pharma USA.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Olanzapine Tablets, USP 7.5 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Potency & Assay | Nationwide |
More recalls from Aurobindo Pharma USA
All 59| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dicyclomine Hydrochloride Capsules, USP, 10mg recalledDicyclomine Hydrochloride | Aurobindo Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nebivolol Tablets recalled by Aurobindo Pharma USANebivolol | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 90 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 30 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
Other Olanzapine recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Olanzapine Tablets, USP 5 mg recalled by Macleods PharmaceuticalsOlanzapine | Macleods Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Olanzapine Tablets, USP 2.5 mg recalled by Macleods PharmaceuticalsOlanzapine | Macleods Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Olanzapine Tablets, USP 10 mg recalled by Macleods Pharma UsaOlanzapine | Macleods Pharma Usa | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Olanzapine Tablets, USP 7.5 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Olanzapine Tablets, 20 mg recalled by Sun Pharmaceutical Industries | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |