CLASS II Drug recall · Reported 11 Dec 2019 · FDA Enforcement Report
Exparel, Bupivicaine Liposome Injectable Suspension recalled
Pacira Pharmaceuticals is recalling Exparel, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/ (13 mg/mL), Sterile, distributed nationwide in the US. The recall was initiated on 21 Nov 2019 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-0621-2020
- FDA event ID
- 84311
- Recalling firm
- Pacira Pharmaceuticals, San Diego, CA
- Brand
- Exparel
- Manufacturer
- Pacira Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Nov 2019
- FDA classified
- 10 Dec 2019
- Reported
- 11 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Nov 2019 | Recall initiated by company | |
| 10 Dec 2019 | Classified by FDA | +19 days |
| 11 Dec 2019 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sub Potent Drug: Out of Specification (OOS)
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, Bupivicaine Liposome Injectable Suspension, 1.3%, 266 mg/20 mL (13 mg/mL), Sterile, 20 mL vial, Rx only, Manufactured by: Pacira Pharmaceuticals, Inc. San Diego, CA 92121. NDC: 65250-266-20,
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Sub Potent Drug: Out of Specification (OOS)
Which lots are affected?
Pacira Lot #: 19-5002, Patheon manufacturer Lot #: 098214; Exp. Date: Dec 2019
Where was it sold?
Distributed Nationwide in the USA
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 (bupivacaine liposome injectable suspension) recalled | Pacira Pharmaceuticals | Potency & Assay | Nationwide |
Other Bupivacaine recalls
All 54| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection recalledBupivacaine Hydrochloride | Huons | Sterility | Nationwide |
| Drug | CLASS II | BUPIVAcaine HCL Sterile injection recalled by Tailstorm Health | Tailstorm Health | Sterility | Nationwide |
| Drug | CLASS II | Sensorcaine (Bupivacaine HCl and Epinephrine Injection recalledSensorcaine | Fresenius Kabi USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection recalledSensorcaine | Fresenius Kabi USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Sensorcaine (Bupivacaine HCl and Epinephrine Injection recalledSensorcaine | Fresenius Kabi USA | Potency & Assay | Nationwide |