CLASS III Drug recall · Reported 15 Feb 2017 · FDA Enforcement Report
Olanzapine tablets, USP, 2.5 mg recalled by Dr. Reddy's Laboratories
Dr. Reddy's Laboratories is recalling Olanzapine tablets, USP, 2.5 mg, distributed nationwide in the US. The recall was initiated on 13 Oct 2016 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-0468-2017
- FDA event ID
- 75442
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Brand
- Olanzapine
- Manufacturer
- Dr. Reddy's Laboratories Ltd.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 13 Oct 2016
- FDA classified
- 3 Feb 2017
- Reported
- 15 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 13 Oct 2016 | Recall initiated by company | |
| 3 Feb 2017 | Classified by FDA | +113 days |
| 15 Feb 2017 | Published in enforcement report | +12 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: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.
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, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
C500202
Where was it sold?
US 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.
More recalls from Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | 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 2.5 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Olanzapine Tablets, USP 7.5 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Potency & Assay | Nationwide |