Bupivacaine Hydrochloride

Bupivacaine Hydrochloride recalls: 17 FDA reports

Recalls involving Bupivacaine Hydrochloride. What was wrong with each batch, and how the FDA graded the risk.

17Reports
8Class I
2Ongoing
2026-04-22Most recent
8 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class II9
Class I8

By year reported

YearReports
20133
20146
20151
20163
20211
20222
20261
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Ma

D-0530-2026  ·  Class II  ·  reported 2026-04-22  ·  Ongoing

Why it was recalled
Lack of Assurance of Sterility
Product
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL ampule), NDC 73293-0002-2 (50 x 2 Single-dose ampules); Distributed: Brookfield Pharmaceuticals, LLC, Brookfield, WI 53005, Made in S. Korea, NDC 71351-022-02 (ampule), NDC 71351-022-10 (10 count ampules), NDC 71351-022-50 (50 count ampules)
Where it went
USA Nationwide.
How much
3,260,170 ampules

Bupivacaine Hydrochloride, USP 0.5% (5mg/mL), 25 vials x 50 mL per box, Rx only, MFG: Pfizer, NDC 0409-1163-01

D-1095-2022  ·  Class II  ·  reported 2022-06-15  ·  Terminated

Why it was recalled
cGMP deviations: Temperature abuse
Product
Bupivacaine Hydrochloride, USP 0.5% (5mg/mL), 25 vials x 50 mL per box, Rx only, MFG: Pfizer, NDC 0409-1163-01
Where it went
USA nationwide.
How much
30 vials

Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25/ct), Rx only, Manufacturer: Auro

D-0998-2022  ·  Class II  ·  reported 2022-06-15  ·  Terminated

Why it was recalled
cGMP deviations: Temperature abuse
Product
Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25/ct), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-169-10
Where it went
USA nationwide.
How much
224 cartons/10 vials each
Class I

0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 04

D-0626-2021  ·  Class I  ·  reported 2021-06-09  ·  Terminated

Why it was recalled
Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Product
0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL Single-dose Teartop Vials (NDC 0409-1162-19), packaged in 25 vials per tray (NDC 0409-1162-02), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.
Where it went
Nationwide in the USA, Puerto Rico, and Guam
How much
163,957 vials
Class I

Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials,

D-0218-2017  ·  Class I  ·  reported 2016-12-28  ·  Ongoing

Why it was recalled
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Product
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02
Where it went
Nationwide
How much
143,250 vials

Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only,

D-0096-2017  ·  Class II  ·  reported 2016-10-19  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Product
Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1587-50.
Where it went
Nationwide and Puerto Rico
How much
15 vials

Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hos

D-0097-2017  ·  Class II  ·  reported 2016-10-19  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Product
Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.
Where it went
Nationwide and Puerto Rico
How much
4768 vials
Class I

Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSP

D-1216-2015  ·  Class I  ·  reported 2015-07-15  ·  Terminated

Why it was recalled
Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
Product
Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.
Where it went
U.S. Nationwide including Guam.
How much
150,950 Vials
Class I

Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only,

D-0002-2015  ·  Class I  ·  reported 2014-10-08  ·  Terminated

Why it was recalled
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Product
Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (150 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-1560-29
Where it went
Nationwide
How much
40,730 vials

Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and E

D-1588-2014  ·  Class II  ·  reported 2014-09-24  ·  Terminated

Why it was recalled
Presence of Particulate Matter: A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial.
Product
Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural Anesthesia, Not for Spinal Anesthesia, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1162-02
Where it went
Nationwide
How much
75,000 vials
Class I

Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only,

D-1358-2014  ·  Class I  ·  reported 2014-06-11  ·  Terminated

Why it was recalled
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.
Product
Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045 USP, NDC 0409-1559-10.
Where it went
Nationwide.
How much
85,680 vials
Class I

Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-co

D-1161-2014  ·  Class I  ·  reported 2014-03-26  ·  Terminated

Why it was recalled
Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
Product
Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.
Where it went
Nationwide
How much
40,360 vials

Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., La

D-1147-2014  ·  Class II  ·  reported 2014-03-12  ·  Terminated

Why it was recalled
Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.
Product
Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1162-02
Where it went
Nationwide
How much
115,500 Vials

0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc.

D-395-2014  ·  Class II  ·  reported 2014-01-08  ·  Terminated

Why it was recalled
Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
Product
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.
Where it went
US Nationwide.
How much
65109 vials
Class I

0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC

D-380-2014  ·  Class I  ·  reported 2013-12-25  ·  Terminated

Why it was recalled
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Product
0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1159-02
Where it went
Nationwide
How much
118,100 vials
Class I

0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC

D-381-2014  ·  Class I  ·  reported 2013-12-25  ·  Terminated

Why it was recalled
Presence of particulate matter: visible free floating and partially embedded particulate matter in the glass vials.
Product
0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1165-02
Where it went
Nationwide
How much
119,600 vials

0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc.,

D-66295-001  ·  Class II  ·  reported 2013-10-16  ·  Terminated

Why it was recalled
Lack of Assurance of Sterility; potential for vial breakage
Product
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045
Where it went
Nationwide and Guam and Abu Dhabi
How much
187,150 vials
Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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