Agency classClass IIOur severity:High FDA (Drugs)·D-1070-2023·Announced 2023-08-09

Fentanyl and Bupivacaine Injectable Recalled for Sterility Concerns

Central Admixture Pharmacy Services is recalling 1,114 bags of fentanyl and bupivacaine injectable due to lack of validation data for sterilization. The product was distributed 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: FDA Class II recall of a sterile injectable with no reported illnesses or injuries. The hazard—lack of sterilization validation—is theoretical, not confirmed contamination. This meets the rubric criteria for High (score 3): risk-of-harm products where injury has not yet been reported.

Plain-English summary

Central Admixture Pharmacy Services, Inc. is recalling 1,114 bags of a compounded injectable medication containing fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride (100 mL bags, NDC 71286-2082-1) that was distributed nationwide.

The recall is due to lack of validation data for sanitization cycles, which means the manufacturer cannot assure the sterility of the product. Compounded sterile injectables require validated sterilization procedures to prevent microbial contamination.

Healthcare providers and facilities should check their inventory for the affected lot numbers. Those who have received affected product should follow guidance from the FDA and the manufacturer regarding product disposition.

The recalled product

Product: fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 100 mL, Total FentaNYL 200 mcg/100 mL, 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2082-1
Manufacturer: Central Admixture Pharmacy Services Inc
Category: Drug — Compounded Injectable
Hazard: lack-of-sterility
contamination
Affected units: 1,114

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 (17)

Lot: 17-274485
Exp. 9/19/2023
17-270783
Exp. 7/19/2023
17-270882
Exp. 7/20/2023
17-271430
Exp. 7/30/2023
17-271509
Exp. 7/31/2023
17-272224
17-272238
Exp. 8/13/2023
17-272704
Exp. 8/21/2023
17-273147
Exp. 8/29/2023.

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 →

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