Amphotericin B Liposome Injection Recalled for Subpotency Nationwide
Sun Pharmaceutical recalled Amphotericin B Liposome for Injection due to subpotent drug content. The recall involved 12,960 vials distributed nationwide across the United States.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for subpotent drug content, which presents a risk of reduced treatment efficacy. No reported illnesses or injuries are mentioned in the source. Per the severity rubric, this qualifies as High (Score 3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Amphotericin B Liposome for Injection, 50mg/vial, has been recalled by Sun Pharmaceutical Industries, Inc. due to subpotency in the affected batches. The product is manufactured by Sun Pharmaceutical Medicare Limited in India and distributed from the company's New Jersey facility.
The affected lots are Lot BAD0089A (expiration 01/2025) and Lot BAD0330A (expiration 07/2025), NDC 62756-0233-01. Approximately 12,960 vials were distributed nationwide to hospitals and healthcare facilities across the United States.
The recall was initiated on May 30, 2023, and was terminated as of December 18, 2023.
The recalled product
- Product
- Amphotericin B Liposome for Injection, 50mg/vial, 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 62756-0233-01
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Injectable Pharmaceutical
- Hazard
- Affected units
- 12,960
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot # BAD0089A
- Exp 01/2025
- BAD0330A
- Exp 07/2025
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · SUN PHARMACEUTICAL INDUSTRIES INC
See all →- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Specifications
FDA (Drugs) · 2026-10-14
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08
Same hazard · subpotent
See all →- ModerateCAREone Earwax Removal Drops Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2026-07-22
- HighCompounded vasopressin syringes recalled as subpotent by IntegraDose Compounding Services
FDA (Drugs) · 2026-06-24
- ModerateRhonda Allison calming skin gel recalled as a subpotent hydrocortisone product
FDA (Drugs) · 2026-04-22
- ModerateSkin Rehab calming hydrocortisone balm recalled as a subpotent drug
FDA (Drugs) · 2026-04-22
- Moderateglo Skin Beauty Remedy Gel recalled as a subpotent hydrocortisone product
FDA (Drugs) · 2026-04-22
Similar recalls
- HighPrescription antifungal injection product recalled for out-of-specification assay
FDA (Drugs) · 2024-05-15
- LowSun Pharmaceutical Recalls Pantoprazole Sodium Injection Due to Impurity Failures
FDA (Drugs) · 2021-02-17
- HighMedroxyprogesterone acetate injectable vials recalled for lack of sterility assurance
FDA (Drugs) · 2022-06-22
- SevereSun Pharmaceutical Recalls Doxorubicin Hydrochloride Injection Due to Sterility Concerns
FDA (Drugs) · 2018-01-31
- HighSun Pharmaceutical Recalls Decitabine Injection for Microbial Contamination
FDA (Drugs) · 2024-07-10
- LowGabapentin Capsules 400 mg Recalled for Cross Contamination
FDA (Drugs) · 2025-04-16