Princeton, NJ, United States
Bionpharma Inc. recalls
4 recalls recorded since 2018, most recently on 7 August 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)2
Terminated or completed2
Class I (FDA)1
Ongoing Class III Drugs
- Recall started
- 7 August 2026
- Reason
- Presence of Foreign Tablets/Capsules
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0822-2026
- Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc., Princeton, NJ 08540 NDC 69452-206-20.
Ongoing Class II Drugs
- Recall started
- 26 June 2026
- Reason
- Presence of Foreign Tablets/Capsules
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0742-2026
- Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, Made in India, NDC 69452-435-30.
Terminated Class I Drugs
- Recall started
- 17 September 2024
- Terminated
- 16 September 2025
- Reason
- Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
- Distribution
- Nationwide in the U.S.A.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0012-2025
- Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.
Terminated Class II Drugs
- Recall started
- 16 July 2019
- Terminated
- 5 March 2020
- Reason
- Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1519-2019
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.