- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
- Affected products (lot / model / serial)
- Catalog Number: 405609. UDI Numbers: (10)00382904056094(17)261001(10)B01V212D, (10)00382904056094(17)270101(10)B01V238D. Lot Numbers (Expiration Date): B01V212D (2026-10-01), B01V238D (2027-01-01).
- Units affected
- 990 units
- Distribution pattern
- Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY.
- Firm location
- Franklin Lakes, NJ, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2248-2026
- Recall initiated
- April 27, 2026
- FDA classification date
- May 29, 2026
- FDA report date
- June 10, 2026
- FDA event ID
- 98842
- Last updated on HTM Vibe
- July 23, 2026