Where's it on?
FDA · Drugs ·

Busulfan Injection recall

Sagent Pharmaceuticals recalled Busulfan Injection on May 27, 2026 because of failed Impurities/Degradation Specifications. It was sold nationwide.

Why it was recalled

Failed Impurities/Degradation Specifications

What's recalled

Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10.

Quantity: Lot 656412: 6,200 vials. Lot 659646: 3,328 vials.

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Sagent Pharmaceuticals, Schaumburg, IL
Date
Severity
Class III
the product is unlikely to cause health problems but breaks a rule.
Where sold
Nationwide
Nationwide within the United States
Status
Ongoing
Recall number
D-0539-2026
Source
U.S. Food and Drug Administration

More drugs recalls

TRP The Relief Products* Gentle Eyes Lubricant Eye Drops
· Sterling Pharmaceutical Services LLCAvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops
· Sterling Pharmaceutical Services LLCClear Eyes Redness Relief
· Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare companyAvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops
· Sterling Pharmaceutical Services LLCLubricant Eye Drops-Cameron Pharmaceuticals
· Sterling Pharmaceutical Services LLCReliable -1 Laboratories
· Sterling Pharmaceutical Services LLC