Vital Care Trypan Blue Recall: Sterility Risk
Vital Care Compounder recalls Trypan Blue vials due to lack of sterility assurance. Check lot 391462 for details.
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Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
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What happened, in plain English
Vital Care Compounder is recalling Trypan Blue 0.3% in 0.5 mL vials because the aluminum crimps do not fully seal the rubber stopper, leading to a lack of sterility assurance. This recall affects 54 vials distributed in Mississippi with a use-by date of October 6, 2016. The record does not specify what consumers should do with the product. Read more at govinfonow.com/recall/44178-vital-care-compounder-recalls-trypan-blue-0-3-0-5.
Source Summary by GovInfoNow · govinfonow.com/recall/44178-vital-care-compounder-recalls-trypan-blue-0-3-0-5 · Updated October 12, 2026 · FDA enforcement record: FDA #D-1056-2016
Cite this page
“Vital Care Trypan Blue Recall: Sterility Risk.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44178-vital-care-compounder-recalls-trypan-blue-0-3-0-5. Based on FDA recall #D-1056-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1056-2016%22&limit=1).
Why it’s dangerous
The aluminum crimps fail to fully seal the rubber stopper to the vial, which compromises the sterility of the contents and risks contamination.
Who’s affected
Individuals or facilities in Mississippi who purchased Trypan Blue 0.3% vials from Vital Care Compounder before October 6, 2016.
How to tell if you have this one
Look for Trypan Blue 0.3% in 0.5 mL vials manufactured by Vital Care Compounder with Lot number 391462 and a use-by date of 10-06-2016.
- Brand
Vital Care Compounder- Category
Drug
All 3 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
MS
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1054-2016 | Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder, Hattiesburg, MS; Lot#: 389279, Use by 09-09-16 | 39 vials |
| D-1055-2016 | Brilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial, Vital Care Compounder, Hattiesburg, MS; Lot#: 395575, Use by 07-27-2016 | 9 Vials |
| D-1056-2016 | Trypan Blue 0.3%, 0.5 mL Vial, Vital Care Compounder, Hattiesburg, MS; Lot#: 391462, Use by 10-06-2016 | 54 vials |
What to do — step by step
Check Your Product
Verify if your vial matches Lot 391462 and the specified expiration date.
Contact Manufacturer
Reach out to Vital Care Compounder in Hattiesburg, MS for further instructions as no specific remedy is listed in the record.
Where it went and when
Where it was distributed
Distributed in Mississippi.
FDA distribution: “MS” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Mississippi.
Recall timeline
FDA terminated this recall 17 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-1056-2016 (June 10, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1056-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 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.