Vitalab Methylcobalamin Recall: Sterility Risk
Vitalab Pharmacy recalls Methylcobalamin for injection due to lack of sterility assurance. Check lot numbers and expiration dates if you have this drug.
Stop using this now
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
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What happened, in plain English
Vitalab Pharmacy, Inc. is recalling specific lots of Methylcobalamin for injection (1mg/mL and 10 mg/mL) because there is a lack of assurance of sterility. The company determined that airflow patterns may not be sufficient to support aseptic production. This affects patients who received these sterile injectable drugs distributed throughout the United States. Read more at govinfonow.com/recall/40590-vitalab-methylcobalamin-recall-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40590-vitalab-methylcobalamin-recall-sterility-risk · Updated October 11, 2026 · FDA enforcement record: FDA #D-0728-2018
Cite this page
“Vitalab Methylcobalamin Recall: Sterility Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/40590-vitalab-methylcobalamin-recall-sterility-risk. Based on FDA recall #D-0728-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0728-2018%22&limit=1).
Why it’s dangerous
Injectable drugs must be sterile to prevent serious infections when introduced into the body. The recall cites insufficient airflow patterns during production, which means the product may not have been kept aseptic, posing a risk of contamination.
Who’s affected
Patients in the United States who were prescribed or received Methylcobalamin for injection from Vitalab Pharmacy, Inc. are at risk of infection due to potential non-sterile product.
How to tell if you have this one
Look for Methylcobalamin for injection, 1mg/mL or 10 mg/mL, manufactured by Vitalab Pharmacy, Inc. Check if your vial has one of the following lot numbers: 02122018@77, 03092018@52, 02122018@76, 03142018@32, 01312018@40, 12282017@31, 01232018@17, 03052018@54, 03082018@39, 02082018@55, 02082018@56, 03062018@69, 02052018@56, 03122018@62, 02072018@95, 03122018@63, 02072018@96, 03122018@64, or 02072018@97. The expiration dates for these lots range from 05/06/2018 to 09/10/2018.
- Brand
Vitalab Pharmacy- Category
Drug
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
The recalled product was distributed to patients throughout the United States.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0728-2018 | Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc; Lot #: 02122018@77, 03092018@52,02122018@76,03142018@32, 01312018@40, 12282017@31, 01232018@17, 03052018@54, 03082018@39 02082018@55, 02082018@56, 03062018@69, 02052018@56,03122018@62 02072018@95, 03122018@63, 02072018@96, 03122018@64, 02072018@97; Exp 05/06/2018-09/10/2018 | 178 vials |
| D-0729-2018 | Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc; Lot #: 02122018@77, Exp 05/13/2018 | 2 vials |
| D-0730-2018 | Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable, Vitalab Pharmacy, Inc; Lot #: 03092018@52, 02122018@76, Exp 05/13/2018-06/07/2018 | 22 vials |
| D-0731-2018 | Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile injectable, Vitalab Pharmacy, Inc; Lot #: 03052018@54, Exp 06/03/2018 | 3 vials |
| D-0732-2018 | Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab Pharmacy, Inc.; Lot #: 03052018@54 | N/A |
| D-0733-2018 | Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 10mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin 25mcg/mL, sterile injectables, Vitalab Pharmacy, Inc; Lot #:T101 03062018@69, 02052018@56, T104 03122018@62, 02072018@95, T105 03122018@63, 02072018@96, T106 03122018@64, 02072018@97, Exp 06/04/2018-06/10/2018 | 60 vials |
What to do — step by step
Stop using the product
Do not use any vials matching the recalled lot numbers due to sterility concerns.
Contact your healthcare provider
Reach out to the doctor or pharmacist who prescribed or dispensed the medication for guidance on next steps.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “The recalled product was distributed to patients throughout the United States.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0728-2018 (April 24, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0728-2018 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.