CLASS II Drug recall · Reported 6 Dec 2017 · FDA Enforcement Report
Clozapine Tablets USP, 100 mg recalled by Teva Pharmaceuticals U
Teva Pharmaceuticals USA is recalling Clozapine Tablets USP, 100 mg, distributed nationwide in the US. The recall was initiated on 9 Nov 2017 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-0096-2018
- FDA event ID
- 78552
- Recalling firm
- Teva Pharmaceuticals USA, North Wales, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Nov 2017
- FDA classified
- 27 Nov 2017
- Reported
- 6 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 9 Nov 2017 | Recall initiated by company | |
| 27 Nov 2017 | Classified by FDA | +18 days |
| 6 Dec 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications; potential presence of broken tablets.
Product as listed by the FDA
Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem Israel, Manufactured For: TEVA PHARMACEUTICALS USA, North Wales, PA, NDC 00093-7772-05
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications; potential presence of broken tablets.
Which lots are affected?
Lot # 39C192, exp 06/2019
Where was it sold?
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 Teva Pharmaceuticals USA
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|---|---|---|---|---|---|
| Drug | CLASS II | Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets recalledMetoclopramide | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Octreotide Acetate for Injectable Suspension recalledOctreotide Acetate | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) recalledClaravis | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
Other Clozapine recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clozapine Tablets USP tablet, 100mg recalled by Aurobindo Pharma USAClozapine | Aurobindo Pharma USA | Other | Nationwide |
| Drug | CLASS II | Clozapine Orally Disintegrating Tablets, 12.5 mg recalledClozapine | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Clozapine Tablets USP, 25 mg bottle recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals USA | Sterility | Nationwide |