CLASS II Drug recall · Reported 6 Mar 2013 · FDA Enforcement Report
Exparel (bupivacaine liposome injectable suspension) recalled
Pacira Pharmaceuticals is recalling Exparel (bupivacaine liposome injectable suspension), 1.3%, 266 mg/ (13.3 mg/mL) single, distributed nationwide in the US. The recall was initiated on 17 Dec 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-168-2013
- FDA event ID
- 64198
- Recalling firm
- Pacira Pharmaceuticals, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Dec 2012
- FDA classified
- 25 Feb 2013
- Reported
- 6 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Dec 2012 | Recall initiated by company | |
| 25 Feb 2013 | Classified by FDA | +70 days |
| 6 Mar 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent; bupivacaine
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide distribution: AZ, DC, FL, GA, MA, NJ, NY, OH, and TX.
Nationwide ArizonaDistrict of ColumbiaFloridaGeorgiaMassachusettsNew JerseyNew YorkOhioTexas
Questions about this recall
Why was it recalled?
Subpotent; bupivacaine
Which lots are affected?
Lot #11-2005 Control #23542 Manufacture Date: 05Dec11 2011-L-009
Where was it sold?
Nationwide distribution: AZ, DC, FL, GA, MA, NJ, NY, OH, and TX.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pacira Pharmaceuticals
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Zilretta (triamcinolone acetonide extended-release recalledZilretta | Pacira Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Drug Vial Label: Zilretta¿ recalled by Pacira PharmaceuticalsZilretta | Pacira Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Exparel, Bupivicaine Liposome Injectable Suspension recalledExparel | Pacira Pharmaceuticals | Potency & Assay | Nationwide |