Fentanyl Injectable Solution Recalled for Sterility Validation Failure
Central Admixture recalls 8,146 bags of fentanyl injection due to lack of sterilization cycle validation. This Class II recall affects patients nationwide who may receive contaminated IV medication.
What this means for you
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 of a high-risk injectable opioid due to lack of sterilization validation. Although no illnesses or injuries have been reported, the potential for microbial contamination of a potent opioid product poses significant risk to patients receiving intravenous administration.
Plain-English summary
Central Admixture Pharmacy Services Inc. is recalling fentanyl in 0.9% sodium chloride (2500 mcg/250 mL) injectable solution. The recall affects 8,146 bags distributed nationwide, with multiple lot numbers and expiration dates ranging from July through September 2023.
The recall is due to lack of assurance of sterility resulting from lack of validation data for sanitization cycles. The manufacturer failed to adequately validate that its sterilization processes ensure the product remains sterile and safe for intravenous administration.
This prescription fentanyl injection was distributed nationwide in the United States. Fentanyl is a potent opioid used for pain management and anesthesia, typically administered intravenously in healthcare settings. The concern is that patients may have received contaminated medication if affected lots were used.
The recalled product
- Product
- fentaNYL in 0.9% sodium chloride, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable Opioid
- Hazard
- sterility-failure
- microbial-contamination
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 (20)
- Lot: 17-270584
- 17-270586
- 17-270597
- 17-270613
- Exp. 7/17/2023
- 17-270655
- 17-270659
- 17-270741
- Exp. 7/18/2023
- 17-270872
- 17-270875
- Exp. 7/20/2023
- 17-271040
- 17-271041
- 17-271042
- 17-271058
- 17-271066
- 17-271071
- 17-271080
- Exp. 7/24/2023
Distribution
Distributed nationwide across the United States.
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