Multi-event May 2025 FDA Recall Drug by Thrive Health And Wellness, Llc, Dba Thrive Health Solutions
colorado

This Multi-event Class II drug recall was voluntarily initiated by Thrive Health And Wellness, Llc, Dba Thrive Health Solutions (colorado) on May 21, 2025 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently ongoing.

Reported Recall Events

Recall Number: D-0480-2025

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-21-2025
Reported
07-02-2025
Quantity
164 syringes

Recall Profile & Regulatory Data

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
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Batch or Lot Expiration Information

Lot# : C03035J, Exp 7/3/2025, H202959, exp 7/6/2025; AB20N110720 , exp 7/7/2025 ; AB60N1121, exp 7/7/2025; PRX022225-1 , exp 8/24/2025 ; U122024 , exp 10/26/2025

Recall Number: D-0485-2025

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-21-2025
Reported
07-02-2025
Quantity
216 syringes

Recall Profile & Regulatory Data

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
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Batch or Lot Expiration Information

Lot# Lot: C03065F

Recall Number: D-0481-2025

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-21-2025
Reported
07-02-2025
Quantity
28 syringes

Recall Profile & Regulatory Data

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
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Batch or Lot Expiration Information

Lot# Lot: C03075J, Ex p 7/7/2025

Recall Number: D-0478-2025

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-21-2025
Reported
07-02-2025
Quantity
16 syringes

Recall Profile & Regulatory Data

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
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Batch or Lot Expiration Information

Lot# : O-O8A01-25, Exp 3/7/2025

Recall Number: D-0476-2025

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-21-2025
Reported
07-02-2025
Quantity
64 syringes

Recall Profile & Regulatory Data

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
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
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

Batch or Lot Expiration Information

Lot# : H277639, Exp 6/25/2025

Recall Number: D-0474-2025

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-21-2025
Reported
07-02-2025
Quantity
5

Recall Profile & Regulatory Data

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
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Methylcobalamin Injectable, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Batch or Lot Expiration Information

Lot# : H228307, Exp 12/27/2025

Recall Number: D-0482-2025

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-21-2025
Reported
07-02-2025
Quantity
24 syringes

Recall Profile & Regulatory Data

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
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Batch or Lot Expiration Information

Lot# Lot, expiry: H272962, exp 12/5/2025; S5045185, exp 5/20/2025; H272962, exp 12/5/2025; H270625, exp 9/30/2025

Recall Number: D-0477-2025

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-21-2025
Reported
07-02-2025
Quantity
102 syringes

Recall Profile & Regulatory Data

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
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
LX Bioboost Plus, (Each 1mL contains Methionine 25 mg, Inositol 50 mg, Choline Chloride 50 mg, Pyridoxine HCl 25 mg, Dexpanthenol 25 mg, Cyanocobalamin 1 mg, L-Arginine HCl 15 mg, L-Carnitine 15 mg, and Lidocaine 1 mg in SWFI), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Batch or Lot Expiration Information

Lot# : H227226, Exp 12/24/2025; H360175, Exp 6/2/2025; H368308, Exp 6/2/2025; Lot S360175, Exp 6/2/2025

Recall Number: D-0484-2025

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-21-2025
Reported
07-02-2025
Quantity
4 syringes

Recall Profile & Regulatory Data

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
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Batch or Lot Expiration Information

Lot# Lot: H388348

Recall Number: D-0486-2025

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-21-2025
Reported
07-02-2025
Quantity
242 syringes

Recall Profile & Regulatory Data

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
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Batch or Lot Expiration Information

Lot# Lot: C03125A

Recall Number: D-0479-2025

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-21-2025
Reported
07-02-2025
Quantity
32 syringes

Recall Profile & Regulatory Data

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
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Batch or Lot Expiration Information

Lot# : H270221, Exp 12/26/2025

Recall Number: D-0475-2025

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-21-2025
Reported
07-02-2025
Quantity
60 syringes

Recall Profile & Regulatory Data

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
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
CJC-1295 Injectable, 6mg/15mg, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Batch or Lot Expiration Information

Lot# : H261968, Exp 12/23/2025; H261358, Exp 5/13/2025

Recall Number: D-0483-2025

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-21-2025
Reported
07-02-2025
Quantity
826 syringes

Recall Profile & Regulatory Data

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
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Batch or Lot Expiration Information

Lot# BH11235 exp 5/5/2025 ; BH11235 , exp 5/5/2025 ; BH11235 , exp 5/5/2025 ; BH11235 , exp 5/5/2025 ; BH11235 , exp 5/5/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; BH272962 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; BH272962 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; BH00048 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX11212024 , exp 5/20/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRX12825-2 , exp 7/27/2025 ; PRO30625-2 , exp 9/2/2025 ; PRO30625-2 , exp 9/2/2025 ; PRO30625-2 , exp 9/2/2025 ; PRX012825-2 , exp 9/27/2025 ; PRX012825-2 , exp 9/27/2025 ; PRX012825-2 , exp 9/27/2025 ; PRX012825-2 , exp 9/27/2025 ; PRX012825-2 , exp 9/27/2025 ; PRX012825-2 , exp 9/27/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; AB11212024 , exp 11/21/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025 ; BH66-1002 , exp 12/30/2025

Recall Number: D-0487-2025

Reason for Recall
Lack of Assurance of Sterility
Initiated
05-21-2025
Reported
07-02-2025
Quantity
16 syringes

Recall Profile & Regulatory Data

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
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112

Batch or Lot Expiration Information

Lot# Lot: GA37484