LL Bioboost Injectable pre-filled syringes recalled for lack of sterility assurance
Thrive Health and Wellness, LLC is recalling LL Bioboost Injectable pre-filled syringes nationwide due to lack of assurance of sterility. The affected product is Lot #H277639 with expiration 6/25/2025.
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: This is an FDA Class II recall involving a sterile injectable drug where loss of sterility assurance creates risk of serious infection. The hazard—compromised sterility of an injectable—meets the criterion for Severe as a Class II recall with potential for serious health consequences.
Plain-English summary
Thrive Health and Wellness, LLC, doing business as Thrive Health Solutions in Englewood, Colorado, is recalling LL Bioboost Injectable pre-filled syringes nationwide. The recalled product is a 1mL injectable containing Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in Sterile Water for Injection. The affected lot is #H277639 with an expiration date of 6/25/2025, consisting of 64 syringes.
The recall is due to a lack of assurance of sterility. Sterility is critical for injectable products to prevent potentially serious infections. Consumers or healthcare providers who have this product should stop use immediately and contact the manufacturer or their healthcare provider for guidance on safe disposal or replacement.
The recalled product
- Product
- LL Bioboost Injectable, Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, and Cyanocobalamin 1 mg in SWFI, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
- Category
- Drug — Injectable / Supplement
- Affected units
- 64
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 #: H277639
- Exp 6/25/2025
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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