Busulfan recalls

The FDA has published 2 recalls involving Busulfan since 2020. The latest was reported on 27 May 2026. Most were for manufacturing (cgmp) deviations. Sagent Pharmaceuticals has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls2since 2020

Last 12 months1reported

Class I00% of total

Ongoing1latest 27 May 2026

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 0Mar 0 0 0Jun 0 0 0Sep 0 0 0Dec 0 0 0Mar 0 1 0Jun 0 0 0Sep 0 0

Severity split

Class I 0 0%Class II 1 50%Class III 1 50%

Why busulfan is recalled

Manufacturing (CGMP) Deviations150%
Potency & Assay150%

Companies

Sagent Pharmaceuticals150%
Shilpa Medicare150%

By year

2026150%
2020150%

Ongoing busulfan recalls

1 active

Reported	Class	Recall	Company	Reason	Where
27 May 2026Drug	CLASS III	Busulfan Injection, 60 mg per (6 mg per mL), mL Single-Dose Vials recalledBusulfan	Sagent Pharmaceuticals	Potency & Assay	Nationwide

All busulfan recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
27 May 2026Drug	CLASS III	Busulfan Injection, 60 mg per (6 mg per mL), mL Single-Dose Vials recalledBusulfan	Sagent Pharmaceuticals	Potency & Assay	Nationwide
16 Dec 2020Drug	CLASS II	Busulfan Injection 60 mg/ (6 mg/mL) recalled by Shilpa Medicare	Shilpa Medicare	Manufacturing (CGMP) Deviations	Nationwide

Should you stop taking Busulfan?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.