Agency classClass IIOur severity:High FDA (Drugs)·D-0012-2024·Announced 2023-10-11

Fentanyl injectable product recalled for lack of sterility assurance

Central Admixture Pharmacy Services is recalling fentanyl injection product due to lack of sterility assurance. No illnesses have been reported.

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 a sterility assurance failure in an injectable drug product. Although no illnesses or injuries have been reported, lack of sterility in parenteral medications represents a significant risk-of-harm to patients who may experience infection, making this a high-severity recall.

Plain-English summary

Central Admixture Pharmacy Services Inc. is recalling fentanyl in 0.9% sodium chloride, 1,000 mcg/100 mL (10 mcg/mL), supplied in 100 mL bags (prescription only). Approximately 5,378 bags are affected by this recall.

The recall is due to a lack of assurance of sterility. This is an FDA Class II recall. Multiple lot numbers are affected, with expiration dates in October 2023.

The recalled product was distributed nationwide throughout the United States. Patients and healthcare providers in possession of affected units should discontinue use and contact their healthcare provider or the manufacturer for guidance. The specific lot numbers and expiration dates are available in the original FDA recall notice.

The recalled product

Product: fentaNYL in 0.9% sodium chloride, 1,000 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 / Parenteral
Hazard: lack-of-sterility
infection-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: 17-275314
17-275319
17-275320
17-275324
17-275327
17-275328
17-275349
Exp. 10/3/2023
17-275510
17-275531
17-275536
17-275541
17-275548
Exp. 10/5/2023
17-275656
Exp. 10/8/2023
17-275714
Exp. 10/9/2023
17-275766
17-275786

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 32 recalled by Central Admixture Pharmacy Services Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 32 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services Inc

See all →

Moderate
Pediatric TPN Bags Recalled for Incorrect Formulation
FDA (Drugs) · 2026-08-12
Severe
Pediatric Total Parenteral Nutrition Bag Recalled for Incorrect Formulation
FDA (Drugs) · 2026-07-01
Severe
Injectable Phenylephrine Solution Recalled Due to Particulate Matter Contamination
FDA (Drugs) · 2025-03-19
High
Ephedrine Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2023-10-11
High
Fentanyl injectable syringes recalled nationwide for sterility assurance failure
FDA (Drugs) · 2023-10-11

Same hazard · lack of sterility