CLASS II ONGOING Drug recall · Reported 15 May 2024 · FDA Enforcement Report
Amphotericin B Liposome for Injection, 50mg vials recalled
SUN Pharmaceutical Industries is recalling Amphotericin B Liposome for Injection, 50mg vials, distributed nationwide in the US. The recall was initiated on 19 Apr 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0493-2024
- FDA event ID
- 94442
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Brand
- Amphotericin B
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Apr 2024
- FDA classified
- 8 May 2024
- Reported
- 15 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 19 Apr 2024 | Recall initiated by company | |
| 8 May 2024 | Classified by FDA | +19 days |
| 15 May 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Out of specification for assay
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-389350, Gujarat, India. NDC 62756-233-01
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Out of specification for assay
Which lots are affected?
Lot #: BAE0055A, BAE0056A, BAE0068A, Exp. Date 03/2026
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from SUN Pharmaceutical Industries
All 138| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Perampanel CIII Tablets, 6mg recalled by Sun Pharmaceutical IndustriesPerampanel | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension, 1mg recalledBudesonide | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
Other Amphotericin B recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | 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 |