CLASS I Drug recall · Reported 28 Dec 2016 · FDA Enforcement Report

Lidocaine HCL/ Sodium Bicarb, 1%/0.5% SYR PF recalled

Guardian Pharmacy Services is recalling Lidocaine HCL/ Sodium Bicarb, 1%/0.5% SYR PF, distributed in Texas. The recall was initiated on 23 Sep 2016 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot #: 50699:00, Exp 10/04/16

Quantity recalled180 syringes

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-0211-2017
FDA event ID: 75268
Recalling firm: Guardian Pharmacy Services, Dallas, TX
Classification: Class I
Status: Terminated
Recall initiated: 23 Sep 2016
FDA classified: 22 Dec 2016
Reported: 28 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Sterility
Drug class: Pain Medication

Timeline

23 Sep 2016	Recall initiated by company
22 Dec 2016	Classified by FDA	+90 days
28 Dec 2016	Published in enforcement report	+6 days

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

Reason for recall

Non-Sterility: failed sterility test result.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only

Where it was distributed

Two medical facilities in TX

Texas

Questions about this recall

Why was it recalled?

Non-Sterility: failed sterility test result.

Which lots are affected?

Lot #: 50699:00, Exp 10/04/16

Where was it sold?

Two medical facilities in 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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

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 Guardian Pharmacy Services

All 24

Reported	Class	Recall	Company	Reason	Where
15 Aug 2018Drug	CLASS II	Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded recalled	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018Drug	CLASS II	EDTA Disodium 30 mg/mL PF recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018Drug	CLASS II	Magnesium Sulfate 200 mg/mL Rx. Only recalled	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018Drug	CLASS II	Hyaluronidase/mL recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018Drug	CLASS II	Methylcobalamin 1000 mcg/mL recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX

Other Lidocaine recalls

All 119

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