RecallRadar

FDA Drug recall D-0727-2026

Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fr…

On 2026-07-29 the FDA classified a Class II recall of Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fr… by Fresenius Kabi Usa, citing presence of Particulate Matter: Hair was found in products.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0727-2026
ClassificationClass II
Statusongoing
Initiated2026-07-16
Published2026-07-29
Last updated2026-09-13 11:52 UTC
CompanyFresenius Kabi Usa
DistributionUS

Product

Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-05

Reason

Presence of Particulate Matter: Hair was found in products

Identifiers

ndc63323-286-01
ndc63323-286-20
ndc63323-286-05
ndc63323-286-23
ndc63323-286-09
ndc63323-286-31
ndc63323-286-11
ndc63323-286-35
ndc63323-286-03
ndc63323-286-00
ndc63323-286-33
ndc63323-286-63
ndc63323-286-30
ndc63323-287-01
ndc63323-287-20
ndc63323-287-03
ndc63323-287-21
ndc63323-288-01
ndc63323-288-10
ndc63323-288-06
ndc63323-288-20
ndc63323-288-03
ndc63323-288-11
ndc63323-288-07
ndc63323-288-21
ndc63323-285-01
ndc63323-285-10
ndc63323-285-06
ndc63323-285-20
ndc63323-285-03
ndc63323-285-13
ndc63323-285-07
ndc63323-285-23
ndc63323-285-57
ndc63323-285-64
ndc63323-285-51
ndc63323-285-65
ndc63323-285-02
ndc63323-285-61
ndc63323-285-04
ndc63323-285-63
code_infoLot #: 6133436, Exp. Date 10/2028

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0727-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.