Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose recall: Sterility Concern
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio…
Why was Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose recalled?
Lack of Assurance of Sterility
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots within expiry
- Product
- Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio…
- Recalling firm
- Huons Co., Ltd.
- Quantity
- 3,260,170 ampules
- Distribution
- USA Nationwide.
- Recall date
- April 22, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)