Clobazam tablets recalled for contamination with foreign tablets
Amerisource Health Services LLC is recalling Clobazam 10 mg tablets nationwide due to contamination with foreign tablets or capsules. Patients should contact their pharmacist or healthcare provider.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II drug recall involves contamination with foreign tablets or capsules, classified as a risk-of-harm product. No illnesses or injuries are reported in the source material, meeting the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Amerisource Health Services LLC is recalling Clobazam (clobazam tablets, 10 mg) distributed nationwide in the United States due to contamination. The recalled product consists of 30-tablet cartons packaged as 3x10 blister cards, with 4,640 units affected. The lot in question is #1018598 with an expiration date of 10/31/2025.
The recall was initiated because foreign tablets or capsules have been found in affected units. These foreign items pose a potential safety risk if ingested along with the intended medication.
Patients currently taking Clobazam should check the lot number and expiration date on their medication against this recall. Those with the affected product should not continue taking the medication and should contact their pharmacist or healthcare provider immediately for guidance on next steps.
This is an FDA Class II recall.
The recalled product
- Product
- CLOBAZAM (CLOBAZAM)
- Brand
- CLOBAZAM
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug
- Affected units
- 4,640
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 1018598
- Exp. Date 10/31/2025
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CLOBAZAM
- HighClobazam Tablets Recalled for Foreign Tablet Contamination
FDA (Drugs) · 2025-01-15
- HighClobazam tablets recalled nationwide for residual solvent deviation
FDA (Drugs) · 2024-02-28
- SevereBionpharma Recalls Clobazam Oral Suspension Due to Microbial Contamination
FDA (Drugs) · 2019-07-31
Same manufacturer · Amerisource Health Services LLC
See all →- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets 50 mg Recalled for API Cross-Contamination
FDA (Drugs) · 2026-05-27
- HighMeclizine hydrochloride 12.5 mg tablets recalled after failing tablet specifications
FDA (Drugs) · 2026-04-01
- HighOxycodone blister cards recalled over seals that let tablets fall out
FDA (Drugs) · 2026-02-18
- HighUnit dose prazosin 2 mg cartons recalled over nitrosamine impurity
FDA (Drugs) · 2025-11-05
Same hazard · contamination
See all →- SevereEthicon Recalls Silk Surgical Sutures Packaged with Alcohol-Based Fluid
FDA (Devices) · 2026-10-21
- ModerateBioFire FilmArray Pneumonia Panel Plus Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire Joint Infection Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateBioFire FilmArray Pneumonia Panel Recalled for Potential Contamination
FDA (Devices) · 2026-10-21
- ModerateAVID Medical Recalls GYN Laparoscopy Packs Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- HighClobazam Tablets Recalled for Foreign Tablet Contamination
FDA (Drugs) · 2025-01-15
- HighClobazam tablets recalled nationwide for residual solvent deviation
FDA (Drugs) · 2024-02-28
- HighAmerisource Recalls Paroxetine Tablets Due to Foreign Object Presence
FDA (Drugs) · 2017-11-29
- HighAurobindo Recalls Clozapine Tablets Due to Foreign Tablet Presence
FDA (Drugs) · 2020-07-01
- SevereMylan Recalls Mirtazapine Tablets Due to Foreign Glipizide Contamination
FDA (Drugs) · 2017-03-15
- ModerateMetoclopramide Tablets Recalled Due to Presence of Foreign Tablets or Capsules
FDA (Drugs) · 2026-10-21