Bionpharma Recalls Clobazam Oral Suspension Due to Microbial Contamination
Bionpharma Inc. is recalling Clobazam Oral Suspension due to out-of-specification microbial enumeration test results.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves microbial contamination of a prescription drug, which fits the rubric criteria for Severe severity.
Plain-English summary
Bionpharma Inc. is recalling 3,020 bottles of Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottles. The product is distributed nationwide in the USA under NDC 69452-116-45. The specific lot affected is 18246, with an expiration date of 09/2020.
The recall was initiated because out-of-specification results were observed for Microbial Enumeration Tests USP <61>. This indicates microbial contamination of the non-sterile product. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or Bionpharma Inc. for further instructions or a replacement.
The recalled product
- Product
- CLOBAZAM (CLOBAZAM)
- Brand
- CLOBAZAM
- Manufacturer
- Bionpharma Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 3,020
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 #: 18246
- Exp 09/2020
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CLOBAZAM
- HighClobazam tablets recalled for contamination with foreign tablets
FDA (Drugs) · 2025-01-22
- 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
Same manufacturer · Bionpharma Inc.
See all →- ModerateDivalproex Sodium Delayed-Release Tablets Recalled Due to Presence of Foreign Tablets
FDA (Drugs) · 2026-07-29
- SevereAtovaquone Oral Suspension Recalled for Cohnella Bacteria Contamination
FDA (Drugs) · 2024-10-23
Same hazard · microbial contamination
See all →- CriticalVictory Medical Center Pharmacy Recalls Glutathione Vials Due to Contamination
FDA (Drugs) · 2026-08-19
- HighMedline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Recalled Over Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15