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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 5
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.
Part of a larger recall action
This product is one of 14 recalled by Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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