Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported July 31, 2013
AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc., San Dimas, CA 91773, NDC 0469-3051-30.
Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches…
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Gilead Sciences, Inc. recalled AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, S… - a moderate-severity action.
AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, S… was recalled by Gilead Sciences, Inc. in July 31, 2013. Reason: Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contam…. Check the official notice for the remedy. Verify recall #D-821-2013 with the FDA Drug before acting.
The recall
Gilead Sciences, Inc. issued this moderate-severity FDA Drug recall-Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contam….
- Moderate
- severity level
- Class II
- classification
- July 31, 2013
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-821-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-821-2013) was formally reported on July 31, 2013, with the manufacturer initiating the action on June 20, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Gilead Sciences, Inc. is listed as the recalling firm, operating out of Foster City, CA. Federal records list the affected scope as 478,352 vials.
The documented reason for this recall is: Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the fi… Distribution data in the federal record shows the product reached: Foreign distribution only to France, Italy, Switzerland, Portugal, Denmark,Turkey, Ireland, Norway, Malta, UK, Greece, Belgium, Austria, Germany, India, Hong Kong, Israel, Saudi Arabia, Thailand, UAE, Singapore, Ecuador…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
478,352 vials
Related Recalls
6
5 from same agency
Product description
AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc., San Dimas, CA 91773, NDC 0469-3051-30.
Reason for recall
Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the finished product, but there is a possibility of contamination.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-821-2013 |
| Date reported | July 31, 2013 |
| Date initiated | June 20, 2013 |
| Recalling firm | Gilead Sciences, Inc. |
| Firm location | Foster City, CA |
| Affected scope | 478,352 vials |
| Distribution | Foreign distribution only to France, Italy, Switzerland, Portugal, Denmark,Turkey, Ireland, Norway, Malta, UK, Greece, Belgium, Austria, Germany, India, Hong Kong, Israel, Saudi Arabia, Thailand, UAE, Singapore, Ecuador, Oman, El Salvador,… |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-821-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc., San Dimas, CA 91773, NDC 0469-3051-30.. Recalled by Gilead Sciences, Inc.. Units affected: 478,352 vials.
Why was this product recalled? ▼
Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the finished product, but there is a possibility of contamination.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 31, 2013. Severity: Moderate. Recall number: D-821-2013.
Where was the recalled product distributed? ▼
Distribution: Foreign distribution only to France, Italy, Switzerland, Portugal, Denmark,Turkey, Ireland, Norway, Malta, UK, Greece, Belgium, Austria, Germany, India, Hong Kong, Israel, Saudi Arabia, Thailand, UAE, Singapore, Ecuador, Oman, El Salvador, MCF Holland, MSF, France, Ethiopia, Egypt, Argentina, Chile, Brazil, Spain, Finland, Sweden..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-821-2013) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported July 31, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.