Amphotericin B recalls

The FDA has published 2 recalls involving Amphotericin B since 2012. The latest was reported on 15 May 2024. Most were for sterility. SUN Pharmaceutical Industries 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 2012

Last 12 months0reported

Class I00% of total

Ongoing1latest 15 May 2024

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why amphotericin b is recalled

Sterility150%
Potency & Assay150%

Companies

By year

2024150%
2012150%

Ongoing amphotericin b recalls

1 active

Reported	Class	Recall	Company	Reason	Where
15 May 2024Drug	CLASS II	Amphotericin B Liposome for Injection, 50mg vials recalledAmphotericin B	SUN Pharmaceutical Industries	Potency & Assay	Nationwide

All amphotericin b recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
15 May 2024Drug	CLASS II	Amphotericin B Liposome for Injection, 50mg vials recalledAmphotericin B	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
22 Aug 2012Drug	CLASS II	Amphotericin B Ophthalmic, Ll Syringe) P.f. 10mcg/ Injectable recalled	Franck's Lab Inc., d.b.a. Franck's Compounding Lab	Sterility	Nationwide

Should you stop taking Amphotericin B?

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.