The Recall Desk
HighFDA (Drugs)·D-0474-2025·Announced 2025-07-02

Methylcobalamin Injectable Recalled for Lack of Sterility Assurance

Thrive Health Solutions is recalling Methylcobalamin Injectable (10mg/mL, lot H228307) due to lack of assurance of sterility. This product was distributed nationwide and may not meet required sterility standards for injectable medications.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This recall involves a risk-of-harm product (injectable medication with sterility assurance issues) where no illnesses or injuries have been reported in the source text. While the hazard is theoretical rather than confirmed, the potential risk of serious infection from a non-sterile injectable justifies a High severity classification.

Plain-English summary

Thrive Health and Wellness, LLC (dba Thrive Health Solutions) is recalling Methylcobalamin Injectable, 10mg/mL supplied in pre-filled syringes. The affected lot number is H228307 with an expiration date of 12/27/2025. This product was distributed nationwide throughout the USA.

The recall was issued because the manufacturer cannot assure that the product meets required sterility standards. Methylcobalamin is an injectable medication, and sterile conditions are essential to prevent serious infections and other complications that could result from using contaminated products.

Consumers and healthcare providers who have this product should discontinue use. Contact Thrive Health Solutions, your pharmacy, or healthcare provider for instructions on returning or properly disposing of the affected lot. If you have received an injection from this lot, consult your healthcare provider about any appropriate follow-up care.

The recalled product

Product
Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Manufacturer
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Hazard
  • sterility-assurance
  • contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: H228307
  • Exp 12/27/2025

Distribution

Distributed nationwide across the United States.