CLASS II Drug recall · Reported 31 Jul 2019 · FDA Enforcement Report
Clobazam Oral Suspension, 2.5 mg/mL recalled by Bionpharma
Bionpharma is recalling Clobazam Oral Suspension, 2.5 mg/mL, distributed nationwide in the US. The recall was initiated on 16 Jul 2019 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-1519-2019
- FDA event ID
- 83356
- Recalling firm
- Bionpharma, Princeton, NJ
- Brand
- Clobazam
- Manufacturer
- Bionpharma Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jul 2019
- FDA classified
- 25 Jul 2019
- Reported
- 31 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Seizure Medication
Timeline
| 16 Jul 2019 | Recall initiated by company | |
| 25 Jul 2019 | Classified by FDA | +9 days |
| 31 Jul 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 Alexander Road, Princeton, NJ 08540, NDC 69452-116-45.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
Which lots are affected?
Lot #: 18246, Exp 09/2020
Where was it sold?
Nationwide in the USA
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 Bionpharma
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Doxylamine Succinate and Pyridoxine HCl Delayed-Release recalledDoxylamine Succinate And Pyridoxine Hydrochloride | Bionpharma | Other | Nationwide |
| Drug | CLASS II | Divalproex Sodium Delayed-Release Tablets, USP, 500 mg recalledDivalproex Sodium | Bionpharma | Other | Nationwide |
| Drug | CLASS I | Atovaquone Oral Suspension, USP 750 mg recalled by BionpharmaAtovaquone | Bionpharma | Sterility | 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, 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 |