CLASS II Drug recall · Reported 8 Dec 2021 · FDA Enforcement Report
Methylcobalamin Solution for Injection recalled by Asp Cares
ASP Cares is recalling Methylcobalamin Solution for Injection, 1 mg/mL Multiple Dose Vial, For IM, SC or IV Use. The recall was initiated on 17 Nov 2021 and the FDA has classified it as Class II.
Check your package
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-0260-2022
- FDA event ID
- 89076
- Recalling firm
- ASP Cares, San Antonio, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Nov 2021
- FDA classified
- 26 Nov 2021
- Reported
- 8 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Nov 2021 | Recall initiated by company | |
| 26 Nov 2021 | Classified by FDA | +9 days |
| 8 Dec 2021 | 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 Assurance of Sterility
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 Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, For IM, SC or IV Use Only, Rx only, ASP Cares2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-565-30
Where it was distributed
United States
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot: 082921565 BUD: 02/25/2022
Where was it sold?
United States
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 89076This product is part of a recall event; the main page for the event is Ascorbic Acid Solution for Injection recalled by Asp Cares.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ascorbic Acid Solution for Injection recalled by Asp Cares | ASP Cares | Sterility | TX | |
| CLASS II | Biotin Solution for Injection, 10 mg/mL Multiple Dose Vial recalled | ASP Cares | Sterility | TX |
More recalls from ASP Cares
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Biotin Solution for Injection, 10 mg/mL Multiple Dose Vial recalled | ASP Cares | Sterility | TX |
| Drug | CLASS II | Ascorbic Acid Solution for Injection recalled by Asp Cares | ASP Cares | Sterility | TX |
Other Methylcobalamin recalls
All 70| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Methylcobalamin Injectable, 10mg/mL, pre-filled syringe recalled | Thrive Health and Wellness, LLC | Sterility | Nationwide |
| Drug | CLASS II | Methylcobalamin 1MG/ML vial) recalled by Pharmacy Innovations | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Methylcobalamin 12.5mg/ML Vial) Injectable Methylcobalamin recalled | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Methylcobalamin Injection Solution, 12.5mg/ml recalled | Northern VA Compounders Pllc | Sterility | Nationwide |
| Drug | CLASS II | Methylcobalamin 1mg/mL, a)-vial, b)-vial, Room Temperature recalled | TMC Acquisition | Sterility | Nationwide |