Class IISemaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR2026-04-22
Lack of Assurance of Sterility
Recalling firm: PAYLESS COMPOUNDERS, LLC
Class IISemaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04; e) 100g, NDC 84385-106-05Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China.2026-03-11
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Recalling firm: Harbin Jixianglong Biotech Co., Ltd.
Class IISemaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-062026-03-11
Lack of Assurance of Sterility
Recalling firm: New Life Pharma LLC
Class IISemaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.2026-03-11
Lack of Assurance of Sterility
Recalling firm: New Life Pharma LLC
Class IISemaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 84385-106-06; d) 25g, NDC 84385-106-03; d) 50g, NDC 84385-106-04 Manufacturer: Harbin Jixianglong Biotech Co., Ltd., North of Baoan Road, East of Changqing Street, Limin Development Zone, Harbin, China2026-03-11
CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Recalling firm: Harbin Jixianglong Biotech Co., Ltd.
Class IIWegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4501-142026-01-07
Presence of Particulate Matter: Hair was found in a prefilled syringe
Recalling firm: Novo Nordisk Inc.
Class IIWegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Product of Denmark, Novo Nordisk A/S, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-4505-142026-01-07
Presence of Particulate Matter: Hair was found in a prefilled syringe
Recalling firm: Novo Nordisk Inc.
Class IISemaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-042025-11-05
Lack of Assurance of Sterility
Recalling firm: ProRx LLC
Class IISemaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-082025-11-05
Lack of Assurance of Sterility
Recalling firm: ProRx LLC
Class IISemaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-062025-11-05
Lack of Assurance of Sterility
Recalling firm: ProRx LLC
Class IISemaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-092025-11-05
Lack of Assurance of Sterility
Recalling firm: ProRx LLC
Class IISemaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-092025-11-05
Lack of Assurance of Sterility
Recalling firm: ProRx LLC
Class IISemaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-022025-11-05
Lack of Assurance of Sterility
Recalling firm: ProRx LLC
Class IISemaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness, 20 mg, 10mL vial lyophilized.2025-10-15
Lack of Assurance of Sterility
Recalling firm: GenoGenix LLC
Class IISemaglutide with B12 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.2025-10-15
Lack of Assurance of Sterility
Recalling firm: GenoGenix LLC
Class IISemaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.2025-08-13
Lack of Processing Controls.
Recalling firm: AEQUITA PHARMACY
Class IISemaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.2025-08-13
Lack of Processing Controls.
Recalling firm: AEQUITA PHARMACY
Class IISemaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.2025-08-13
Lack of Processing Controls.
Recalling firm: AEQUITA PHARMACY
Class IISemaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.2025-08-13
Lack of Processing Controls.
Recalling firm: AEQUITA PHARMACY
Class IISemaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.2025-08-13
Lack of Processing Controls.
Recalling firm: AEQUITA PHARMACY
Class IISemaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.2025-08-13
Lack of Processing Controls.
Recalling firm: AEQUITA PHARMACY
Class IISemaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 801122025-07-02
Lack of Assurance of Sterility
Recalling firm: Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Class IISemaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 801122025-07-02
Lack of Assurance of Sterility
Recalling firm: Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Class IISemaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 801122025-07-02
Lack of Assurance of Sterility
Recalling firm: Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado)
Class IIWegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, DK-2880, Bagsvaerd, Denmark, NDC 0169-4524-14.2025-05-07
Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products labeled storage conditions due to a shipping error involving a Cardinal Health dis
Recalling firm: Cardinal Health Inc.
Class IISemaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-012024-09-11
Lack of Assurance of Sterility
Recalling firm: ProRx LLC
Class IISemaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-7008, NDC 84139-225-022024-09-11
Lack of Assurance of Sterility
Recalling firm: ProRx LLC
Class IISEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-012024-09-11
Lack of Assurance of Sterility
Recalling firm: ProRx LLC
Class IISEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-042024-09-11
Lack of Assurance of Sterility
Recalling firm: ProRx LLC
Class IIC-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder 115 South 40th Ave, Suite A Hattiesburg, MS 394022023-04-26
Lack of assurance of sterility.
Recalling firm: Pharmacy Plus, Inc. dba Vital Care Compounder
Class IISEMAGLUTIDE 0.5MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 1MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 2MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 4MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 5.4MG/ML (0.5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.2023-02-01
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Recalling firm: Pharmacy Innovations
Class IISEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN, various amounts in unit dose vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 394022022-11-09
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Recalling firm: Pharmacy Plus, Inc. dba Vital Care Compounder
Class IISemaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.2022-09-21
Lack of Assurance of Sterility
Recalling firm: Carolina Infusion
Class IISemaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.2022-09-21
Lack of Assurance of Sterility
Recalling firm: Carolina Infusion
Class IISemaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.2022-09-21
Lack of Assurance of Sterility
Recalling firm: Carolina Infusion
Class IISemaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made Compounding2022-07-20
Lack of Assurance of Sterility
Recalling firm: TMC Acquisition LLC dba Tailor Made Compounding
Class IISemaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made Compounding2022-07-20
Lack of Assurance of Sterility
Recalling firm: TMC Acquisition LLC dba Tailor Made Compounding
Class IIRybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30 tablets 3 blister packs. Each pack contains 10 tablets. Rx only NDC 0169-4307-13 Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd, Denmark2021-06-02
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm: Cardinal Health Inc.
Class IIOZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample. Not for Resale, Rx only, Novo Nordisk Inc, Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-4132-90 (Pen), NDC 0169-4132-97 (Kit)2021-04-21
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to th
Recalling firm: Novo Nordisk Inc