Agency classClass IIOur severity:High FDA (Drugs)·D-1063-2023·Announced 2023-08-09

Fentanyl Injectable Recalled for Lack of Sterility Assurance

Central Admixture Pharmacy Services is recalling 1,044 bags of fentanyl injectable solution due to lack of validated sanitization procedures that could compromise sterility assurance. The product affects healthcare facilities nationwide.

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 of an injectable opioid product due to lack of validated sanitization procedures. Fentanyl is a risk-of-harm product, and while no illnesses or injuries have been reported, the potential for serious harm from non-sterile injections meets the High severity criterion.

Plain-English summary

Central Admixture Pharmacy Services Inc is recalling 1,044 bags of fentanyl injectable solution (5000 mcg/250 mL). The product is supplied in sterile preparation bags for intravenous use and was distributed nationwide.

The manufacturer and FDA identified that the product lacks adequate assurance of sterility. Specifically, the sanitization cycles used in manufacturing lack validation data to ensure they are effective.

Fentanyl is a potent opioid used in clinical and hospital settings. Any potential compromise to sterility could pose a risk to patients who receive the product.

Healthcare facilities that received this product should stop using it and follow the recall instructions provided by Central Admixture Pharmacy Services Inc. Healthcare providers should monitor any patients who may have received fentanyl from these affected lots.

The recalled product

Product: fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2074-1
Manufacturer: Central Admixture Pharmacy Services Inc
Category: Drug — Compounded Injectable
Hazard: sterility-assurance
contamination-risk
Affected units: 1,044

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: 17-271115
Exp. 7/25/2023
17-271398
Exp. 7/30/2023
17-272278
Exp. 8/14/2023
17-272449
Exp. 8/16/2023
17-272521
Exp. 8/17/2023
17-272900
Exp. 8/23/2023
17-273146
Exp. 8/29/2023
17-273236
Exp. 8/30/2023
17-273404
Exp. 9/3/2023
17-273678
Exp. 9/6/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 39 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 39 products in this recall →

Same manufacturer · Central Admixture Pharmacy Services Inc

See all →

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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 · sterility assurance