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

Methylcobalamin Injectable Pre-filled Syringe Recalled for Sterility Concerns

Thrive Health Solutions is recalling Methylcobalamin Injectable 10mg/mL pre-filled syringes (Lot #H228307, expiration 12/27/2025) due to lack of assurance of sterility. The affected product was distributed nationwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA has classified this as a Class II recall. Sterility assurance issues in injectable products pose a risk of serious infection and carry inherent risk of harm to patients; although no reported illnesses or injuries are stated in the source, the hazard (contamination via non-sterile injectable) and Class II designation meet the criteria for Severe.

Plain-English summary

Thrive Health and Wellness, LLC, dba Thrive Health Solutions, is recalling Methylcobalamin Injectable, 10mg/mL, pre-filled syringe distributed nationwide. The affected lot is Lot #H228307 with an expiration date of 12/27/2025. The product contains 5 units.

The recall has been initiated due to lack of assurance of sterility. Injectable products must maintain strict sterility standards to prevent infection when administered to patients.

Consumers who have received this product should contact their healthcare provider or pharmacist immediately. The FDA is overseeing this Class II recall.

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
  • injection-safety
  • infection-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.