Bionpharma recalls Clobazam oral suspension (2.5 mg/mL, 120mL) due to microbial contamination. This may cause health risks if used. Affected lots: 18246 (exp 09/2020).
“Bionpharma Clobazam Oral Suspension Recall: Microbial Contamination Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38276-bionpharma-clobazam-oral-suspension-recall-microbial-contamination-risk. Based on FDA recall #D-1519-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1519-2019%22&limit=1).
The FDA announced on July 16, 2019, that Bionpharma Inc. voluntarily recalled Clobazam Oral Suspension due to microbial contamination risks. The recall affects 3,020 bottles distributed nationwide.
How to tell if you have it
Brand: Bionpharma
Product: Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle
NDC: 69452-116-45
Lot #: 18246
Expiration: 09/2020
Distribution: Nationwide in the USA
The hazard
The recall was initiated because out-of-specification results for Microbial Enumeration Tests USP were observed. This indicates microbial contamination of the non-sterile product.
Context
GovInfoNow's records show Bionpharma Inc. has had three other recalls since September 17, 2024. Recent brand recalls include a Doxylamine-Pyridoxine tablet recall on August 7, 2026, and a Divalproex Tablet recall on June 26, 2026, both involving foreign tablets. Other recent recalls of similar products include a Famotidine Injection recall by Fresenius Kabi (November 6, 2025), a Nebivolol Tablets recall by Glenmark (November 18, 2025), and a Saline Nasal Spray recall by Beekeeper's Naturals (June 1, 2026).
How to tell if you have this one
Check for the product name 'Clobazam Oral Suspension', 2.5 mg/mL concentration, 120mL bottle, and prescription label. The lot number 18246 (expiring September 2020) is affected.
Brand
Bionpharma
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the lot number 18246 on the bottle label, which expires September 2020.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-1519-2019 (July 16, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1519-2019 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.