Fentanyl IV Bags Recalled for Lack of Sterilization Validation
Central Admixture Pharmacy Services is recalling 19,014 bags of fentanyl IV injection nationwide due to lack of validated sterilization processes, which could affect product sterility.
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 with a theoretical contamination hazard based on lack of sterilization validation data. No illnesses or injuries have been reported. Per the rubric, recalls with theoretical hazards and no reported harm score at most 3.
Plain-English summary
Central Admixture Pharmacy Services Inc is recalling 19,014 bags of fentanyl in 0.9% sodium chloride injection (1000 mcg/100 mL, 10 mcg/mL). The recall was initiated due to lack of assurance of sterility, specifically due to lack of validation data for sanitization cycles used in the manufacturing process.
Fentanyl is a potent opioid medication used in hospitals and clinical settings, typically administered intravenously for pain management. If the product was not properly sterilized through validated sanitization cycles, it could be contaminated with bacteria or other microorganisms, which could cause infections in patients receiving the medication.
The recalled product was distributed nationwide in the United States. Multiple lot numbers are affected, with expiration dates ranging from July 16, 2023 to September 12, 2023. The recall number is D-1059-2023.
The recalled product
- Product
- fentaNYL in 0.9% sodium chloride, 1000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-4
- Manufacturer
- Central Admixture Pharmacy Services Inc
- Category
- Drug — Injectable Opioid
- Hazard
- sterility-risk
- contamination-risk
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: 17-270499
- 17-270500
- 17-270503
- 17-270511
- 17-270518
- 17-270544
- Exp. 7/16/2023
- 17-270778
- 17-270779
- Exp. 7/19/2023
- 17-270957
- 17-270958
- 17-270959
- 17-270965
- 17-270972
- 17-270982
- 17-270984
- 17-270985
- Exp. 7/23/2023
- 17-271043
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-06-17
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- SevereCIMZIA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-05-27