Food, drugs, devices › Pacira Pharmaceuticals, Inc.
Drug recall: EXPAREL (bupivacaine liposome injectable suspension), 1.3%, 266 mg/20 mL (13.3 mg/mL) single use vials, INVESTIGATIONAL
FDA enforcement event 64198 is a drug recall by Pacira Pharmaceuticals, Inc. of San Diego, CA, initiated 17 Dec 2012 and classified Class II, with 1 product record.
FDA defines Class II as 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. 56% of the 209 drug enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 3 May 2013. Initiation: voluntary: firm initiated. Pacira Pharmaceuticals, Inc. has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Pacira Pharmaceuticals, Inc., San Diego, CA.
Reason for recall
"Subpotent; bupivacaine"
Distribution
"Nationwide distribution: AZ, DC, FL, GA, MA, NJ, NY, OH, and TX."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-168-2013 | EXPAREL (bupivacaine liposome injectable suspension), 1.3%, 266 mg/20 mL (13.3 mg/mL) single use vials, INVESTIGATIONAL USE. For Infiltration Only. Not for any other route of administration. Manufactured by Paelra Pharmaceuticals. Inc., San Diego, California, USA | 324 vials | Class II | Terminated | 6 Mar 2013 |
Context
Other enforcement events for Pacira Pharmaceuticals, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 12 Jun 2024 | Zilretta (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Manufactured for: Pa | Drug | Class II | 1 |
| 7 May 2024 | Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectable suspension), 32 mg per vial, Rx only, Ma | Drug | Class II | 1 |
| 21 Nov 2019 | EXPAREL, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 mg/mL), Sterile, 20 mL vial, Rx only, Manufa | Drug | Class II | 1 |
All 4 events for Pacira Pharmaceuticals, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Subpotent; bupivacaine"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide distribution: AZ, DC, FL, GA, MA, NJ, NY, OH, and TX."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 May 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.