CLASS II Drug recall · Reported 25 Jul 2018 · FDA Enforcement Report

Methylcobalamin 1mg/mL Injection w/Pres recalled

La Vita Compounding Pharmacy is recalling Methylcobalamin 1mg/mL Injection w/Pres, distributed in California. The recall was initiated on 25 Jun 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #s: 139140@3, Exp 07/23/2018; 141106@1, Exp 08/21/2018; 142919@13, Exp 09/17/2018; 143291@6, Exp 09/23/2018; 145701@3, Exp 10/29/2018; 146932@3, Exp 11/19/2018

Quantity recalled19,040 mL total dispensed in 10 mL and 30 mL vials

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-0921-2018
FDA event ID: 80416
Recalling firm: La Vita Compounding Pharmacy, San Diego, CA
Classification: Class II
Status: Terminated
Recall initiated: 25 Jun 2018
FDA classified: 13 Jul 2018
Reported: 25 Jul 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

25 Jun 2018	Recall initiated by company
13 Jul 2018	Classified by FDA	+18 days
25 Jul 2018	Published in enforcement report	+12 days

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

Reason for recall

Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.

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

Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), packaged in 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500

Where it was distributed

Product was distributed to patients via patient specific prescription only in CA.

California

Questions about this recall

Why was it recalled?

Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.

Which lots are affected?

Lot #s: 139140@3, Exp 07/23/2018; 141106@1, Exp 08/21/2018; 142919@13, Exp 09/17/2018; 143291@6, Exp 09/23/2018; 145701@3, Exp 10/29/2018; 146932@3, Exp 11/19/2018

Where was it sold?

Product was distributed to patients via patient specific prescription only in CA.

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.

Other products in this recall event

2 other products · FDA event 80416

This product is part of a recall event; the main page for the event is Methyl Folate CA+ 1mg/ml Injection w/Pres recalled.

Reported	Class	Recall	Company	Reason	Where
25 Jul 2018	CLASS II	Methyl Folate CA+ 1mg/ml Injection w/Pres recalled	La Vita Compounding Pharmacy	Sterility	CA
25 Jul 2018	CLASS II	Glutathione 200mg/mL Injection w/Pres recalled	La Vita Compounding Pharmacy	Sterility	CA

More recalls from La Vita Compounding Pharmacy

All 3

Reported	Class	Recall	Company	Reason	Where
25 Jul 2018Drug	CLASS II	Glutathione 200mg/mL Injection w/Pres recalled	La Vita Compounding Pharmacy	Sterility	CA
25 Jul 2018Drug	CLASS II	Methyl Folate CA+ 1mg/ml Injection w/Pres recalled	La Vita Compounding Pharmacy	Sterility	CA

Other Methylcobalamin recalls

All 70

Reported	Class	Recall	Company	Reason	Where
2 Jul 2025Drug	CLASS II	Methylcobalamin Injectable, 10mg/mL, pre-filled syringe recalled	Thrive Health and Wellness, LLC	Sterility	Nationwide
1 Feb 2023Drug	CLASS II	Methylcobalamin 1MG/ML vial) recalled by Pharmacy Innovations	Pharmacy Innovations	Sterility	Nationwide
1 Feb 2023Drug	CLASS II	Methylcobalamin 12.5mg/ML Vial) Injectable Methylcobalamin recalled	Pharmacy Innovations	Sterility	Nationwide
18 Jan 2023Drug	CLASS II	Methylcobalamin Injection Solution, 12.5mg/ml recalled	Northern VA Compounders Pllc	Sterility	Nationwide
20 Jul 2022Drug	CLASS II	Methylcobalamin 1mg/mL, a)-vial, b)-vial, Room Temperature recalled	TMC Acquisition	Sterility	Nationwide