Clobazam Tablets recall
FDA recall D-0201-2025 · initiated Jan 7, 2025
Amerisource Health Services LLC recalled Clobazam Tablets in Jan 2025 — an FDA Class II recall (D-0201-2025) because Presence of Foreign Tablets/Capsules.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Foreign Tablets/Capsules
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4640 units
Details
- Product
- 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
- Recalling company
- Amerisource Health Services LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Jan 7, 2025
- FDA report date
- Jan 22, 2025
Frequently asked
- Was Clobazam Tablets recalled?
- Amerisource Health Services LLC recalled Clobazam Tablets in Jan 2025 — an FDA Class II recall (D-0201-2025) because Presence of Foreign Tablets/Capsules. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Clobazam Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0201-2025 was: Presence of Foreign Tablets/Capsules
- Is a recalled Clobazam Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Clobazam Tablets are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: 1018598, Exp. Date 10/31/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0201-2025.