CLASS II ONGOING Drug recall · Reported 22 Jan 2025 · FDA Enforcement Report
Clobazam Tablets, 10 mg recalled by Amerisource Health Services
Amerisource Health Services is recalling Clobazam Tablets, 10 mg, distributed nationwide in the US. The recall was initiated on 7 Jan 2025 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-0201-2025
- FDA event ID
- 96117
- Recalling firm
- Amerisource Health Services, Columbus, OH
- Brand
- Clobazam
- Manufacturer
- American Health Packaging
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Jan 2025
- FDA classified
- 14 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Reason category
- Packaging Defects
- Drug class
- Seizure Medication
Timeline
| 7 Jan 2025 | Recall initiated by company | |
| 14 Jan 2025 | Classified by FDA | +7 days |
| 22 Jan 2025 | Published in enforcement report | +8 days |
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 Tablets/Capsules
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-423-11
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules
Which lots are affected?
Lot #: 1018598, Exp. Date 10/31/2025
Where was it sold?
Nationwide within the United States
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 Amerisource Health Services
All 69| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Primidone Tablets, USP, 250 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) [] recalledMeclizine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride | Amerisource Health Services | Nitrosamine Impurity | Nationwide |
Other Clobazam recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clobazam Tablets, 10 mg recalled by Amerisource Health ServicesClobazam | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Clobazam Tablets 10mg recalled by Micro LabsClobazam | Micro Labs | Potency & Assay | Nationwide |
| Drug | CLASS II | Clobazam Tablets, 20 mg, CIV recalled by Breckenridge Pharmaceutical | Breckenridge Pharmaceutical | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clobazam Tablets, 10 mg, CIV recalled by Breckenridge Pharmaceutical | Breckenridge Pharmaceutical | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Clobazam Oral Suspension 2.5 mg/mL recalled by VistaPharm | VistaPharm | Potency & Assay | Nationwide |