Class II · Moderate risk
Clobazam Tablets
Presence of Foreign Tablets/Capsules
Clobazam Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Foreign Tablets/Capsules
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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
Affected NDC
60687-0423-11
Compare with the code on your package — it is the most precise check available.
Drug: Clobazam
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Clobazam NDC 60687-0423 |
10 mg/1 | Tablet Oral |
American Health Packaging | Rx · CIV |
- Recalling firm
- Amerisource Health Services LLC
- NDC code
- 60687-423-11
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0201-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Clobazam recalls
See all
Class II · Moderate risk
Clobazam Tablets 10mg
CGMP Deviations: Out of specification for residual solvents.
Class II · Moderate risk
Clobazam Tablets
CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk
Clobazam Tablets
CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk
Clobazam Oral Suspension 2.5 mg/mL
Failed Stability Specifications
Other recalls by Amerisource Health Services LLC
All 2025 recalls
Class III · Low risk
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class III · Low risk
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Class II · Moderate risk
Meclizine Hydrochloride Tablets
Failed tablet specifications.
Class II · Moderate risk
Oxycodone Hydrochloride Tablets
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
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