Bionpharma Inc.

FDA Regulatory Profile

Bionpharma Inc. appears in FDA public data with 4 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0822-2026, Class III) was initiated on Aug 7, 2026. Its most recent FDA inspection ended on Sep 19, 2024 (No Action Indicated (NAI)).

Reviewing Bionpharma Inc. as a supplier? Get its full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site, in Claude, Cursor or ChatGPT.

Get a free API key

Summary

Total Recalls
4 (1 Class I)
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Known Names

Bionpharma, Bionpharma Inc

Recent Recalls

NumberClassProductDate
D-0822-2026Class IIIDoxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx OnAug 7, 2026
D-0742-2026Class IIDivalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed byJun 26, 2026
D-0012-2025Class IAtovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc.Sep 17, 2024
D-1519-2019Class IIClobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: Bionpharma Inc., 600 AlJul 16, 2019

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 19, 2024Princeton, NJDrugsNo Action Indicated (NAI)3011705836
Jun 26, 2017Princeton, NJDrugsNo Action Indicated (NAI)3011705836

FDA Data Dashboard classifications: NAI (no action indicated), VAI (voluntary action indicated), OAI (official action indicated).