CLASS II Drug recall · Reported 10 Oct 2018 · FDA Enforcement Report
Clozapine Orally Disintegrating Tablets, 12.5 mg recalled
Teva Pharmaceuticals USA is recalling Clozapine Orally Disintegrating Tablets, 12.5 mg, distributed nationwide in the US. The recall was initiated on 21 Sep 2018 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-0001-2019
- FDA event ID
- 81068
- Recalling firm
- Teva Pharmaceuticals USA, North Wales, PA
- Brand
- Clozapine
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Sep 2018
- FDA classified
- 1 Oct 2018
- Reported
- 10 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 21 Sep 2018 | Recall initiated by company | |
| 1 Oct 2018 | Classified by FDA | +10 days |
| 10 Oct 2018 | 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 Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
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
Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with 13 on one side and plain on the other side.
Where it was distributed
Distributed nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Which lots are affected?
Lot #: 34034024B, Exp 02/20
Where was it sold?
Distributed nationwide in the USA
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 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 |