CLASS II Drug recall · Reported 1 Jul 2020 · FDA Enforcement Report
Clozapine Tablets USP tablet, 100mg recalled by Aurobindo Pharma USA
Aurobindo Pharma USA is recalling Clozapine Tablets USP tablet, 100mg, distributed nationwide in the US. The recall was initiated on 12 Jun 2020 and the FDA has classified it as Class II.
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-1370-2020
- FDA event ID
- 85852
- Recalling firm
- Aurobindo Pharma USA, East Windsor, NJ
- Brand
- Clozapine
- Manufacturer
- Aurobindo Pharma Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jun 2020
- FDA classified
- 30 Jun 2020
- Reported
- 1 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 12 Jun 2020 | Recall initiated by company | |
| 30 Jun 2020 | Classified by FDA | +18 days |
| 1 Jul 2020 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Product as listed by the FDA
Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-846-05
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Which lots are affected?
Lot #: CZSC20003-A, Exp 1/2022
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 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 Clozapine recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clozapine Orally Disintegrating Tablets, 12.5 mg recalledClozapine | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Clozapine Tablets USP, 100 mg recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Clozapine Tablets USP, 25 mg bottle recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals USA | Sterility | Nationwide |