CLASS II Drug recall · Reported 9 Oct 2013 · FDA Enforcement Report

5% Lidocaine HCl and 7.5% Dextrose Injection, USP Single Dose Ampuls recalled

Hospira is recalling 5% Lidocaine HCl and 7.5% Dextrose Injection, USP Single Dose Ampuls, distributed nationwide in the US. The recall was initiated on 29 Aug 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 23-227-DK

Quantity recalled86,400 ampuls

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-66201-001
FDA event ID: 66201
Recalling firm: Hospira, Lake Forest, IL
Classification: Class II
Status: Terminated
Recall initiated: 29 Aug 2013
FDA classified: 2 Oct 2013
Reported: 9 Oct 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Drug class: Pain Medication

Timeline

29 Aug 2013	Recall initiated by company
2 Oct 2013	Classified by FDA	+34 days
9 Oct 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Presence of Particulate Matter; report of visible particulates in the glass ampule

Product as listed by the FDA

5% Lidocaine HCl and 7.5% Dextrose Injection, USP, 2 mL Single Dose Ampuls, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Presence of Particulate Matter; report of visible particulates in the glass ampule

Which lots are affected?

Lot 23-227-DK

Where was it sold?

Nationwide

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.

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Other Lidocaine recalls

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Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Drug	CLASS II	Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine	Fresenius Kabi USA	Particulate Matter	Nationwide
29 Jul 2026Drug	CLASS III	Lidolog Kit, Kit Contains: Lidocaine HCl Injection recalledLidolog Kit	Asclemed USA	Other	TN
29 Jul 2026Drug	CLASS II	Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine	Fresenius Kabi USA	Particulate Matter	Nationwide
29 Jul 2026Drug	CLASS II	Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg recalledXylocaine	Fresenius Kabi USA	Particulate Matter	Nationwide
8 Jul 2026Drug	CLASS II	Lidocaine HCl Injection USP, 1% (10 mg/mL) single dose ampule recalledLidocaine Hydrochloride	Asclemed USA	Sterility	Nationwide