Every recall, by firm, newest first
Apollo Care, LLC · Columbia, MO
11 recalls · on FDA's 503B register
- Class II, ongoing, reported Aug 19, 2026: Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
11 products recalled
- D-0747-2026 · SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102,...
- D-0748-2026 · SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 1...
- D-0749-2026 · SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 1...
- D-0750-2026 · SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102,...
- D-0751-2026 · SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, C...
- D-0752-2026 · SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102,...
- D-0753-2026 · SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care,...
- D-0754-2026 · SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 ...
- D-0755-2026 · SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, ...
- D-0756-2026 · SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801...
- D-0757-2026 · SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801...
Lupin Pharmaceuticals Inc. · Naples, FL
1 recall
- Class II, ongoing, reported May 27, 2026: Presence of particulate matter: a white thread-like structure in the cartridgeD-0541-2026 · Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupi...
PAYLESS COMPOUNDERS, LLC · Beaverton, OR
1 recall
- Class II, ongoing, reported Apr 22, 2026: Lack of Assurance of SterilityD-0471-2026 · Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Beaverton, OR
Harbin Jixianglong Biotech Co., Ltd. · Haerbin, N/A
2 recalls
- Class II, ongoing, reported Mar 11, 2026: CGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
2 products recalled
- D-0379-2026 · Semaglutide, 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, ND...
- D-0380-2026 · Semaglutide, 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, N...
New Life Pharma LLC · Northvale, NJ
4 recalls
- Class II, ongoing, reported Mar 11, 2026: Lack of Assurance of Sterility
4 products recalled
- D-0392-2026 · Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.
- D-0393-2026 · Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06
- D-0394-2026 · Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03.
- D-0395-2026 · Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04.
Novo Nordisk Inc. · Plainsboro, NJ
2 recalls
- Class II, ongoing, reported Jan 7, 2026: Presence of Particulate Matter: Hair was found in a prefilled syringe
2 products recalled
- D-0244-2026 · Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, ...
- D-0245-2026 · Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, Pr...
ProRx LLC · Exton, PA
14 recalls · on FDA's 503B register
- Class II, ongoing, reported Nov 5, 2025: Lack of Assurance of Sterility
7 products recalled
- D-0114-2026 · Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19...
- D-0115-2026 · Semaglutide 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 ...
- D-0116-2026 · Semaglutide 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...
- D-0117-2026 · Semaglutide 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...
- D-0118-2026 · Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 1...
- D-0119-2026 · Semaglutide 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 1...
- D-0120-2026 · Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19...
- Class II, ongoing, reported Sep 11, 2024: Lack of Assurance of Sterility
7 products recalled
- D-0650-2024 · Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01
- D-0651-2024 · Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01
- D-0652-2024 · SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-01
- D-0653-2024 · SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04
- D-0654-2024 · Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-7008, NDC 84139-225-02
- D-0655-2024 · TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01
- D-0656-2024 · TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02
GenoGenix LLC · Boca Raton, FL
3 recalls · on FDA's 503B register
- Class II, ongoing, reported Oct 15, 2025: Lack of Assurance of Sterility
3 products recalled
- D-0083-2026 · Semaglutide with B12 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
- D-0091-2026 · Semaglutide 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. ...
- D-0092-2026 · Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 3343...
Boothwyn Pharmacy LLC · Kennett Square, PA
3 recalls
- Class II, ongoing, reported Sep 10, 2025: Subpotent Drug
3 products recalled
- D-0606-2025 · Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy
- D-0608-2025 · Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy
- D-0609-2025 · Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy
AEQUITA PHARMACY · Kirkland, WA
13 recalls
- Class II, ongoing, reported Aug 13, 2025: Lack of Processing Controls.
13 products recalled
- D-0553-2025 · Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, Multi Dose Vial, ...
- D-0554-2025 · Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi Dose Vial, R...
- D-0555-2025 · Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, ...
- D-0556-2025 · Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial,...
- D-0557-2025 · Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial,...
- D-0558-2025 · Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Via...
- D-0559-2025 · Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial,...
- D-0560-2025 · Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 3 x 2 mL Multi Dose ...
- D-0561-2025 · Semaglutide + 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 ...
- D-0562-2025 · Semaglutide + 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 V...
- D-0563-2025 · Semaglutide +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 Via...
- D-0564-2025 · Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Steril...
- D-0565-2025 · Semaglutide + 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 V...
Thrive Health and Wellness, LLC, dba Thrive Health Solutions (Colorado) · Englewood, CO
8 recalls
- Class II, ongoing, reported Jul 2, 2025: Lack of Assurance of Sterility
8 products recalled
- D-0479-2025 · Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
- D-0480-2025 · Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
- D-0481-2025 · Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood,...
- D-0482-2025 · Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
- D-0483-2025 · Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
- D-0484-2025 · Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
- D-0485-2025 · Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood...
- D-0486-2025 · Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Sui...
Cardinal Health Inc. · Dublin, OH
2 recalls
- Class II, ongoing, reported May 7, 2025: 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 distribution center. More specifically, product was removed from refrigerated storage for an extended period of time and inappropriately released.D-0393-2025 · Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx Only, Single-Dose Onl...
- Class II, terminated, reported Jun 2, 2021: CGMP Deviations: Intermittent exposure to temperature excursion during storage.D-0536-2021 · Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30 tablets 3 blister packs. Each pack contains 10 table...
Revive Rx LLC dba Revive Rx Pharmacy · Houston, TX
2 recalls
- Class I, ongoing, reported Jun 5, 2024: Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionateD-0511-2024 · Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, This is a Compounded Product By: Revive RX Pharmacy, 3831 Golf Dr ...
- Class II, ongoing, reported May 31, 2023: Sub-potent DrugD-0771-2023 · Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use Only, Compounded Drug Product By: Revive Rx, 3831 Golf Dr A, Hou...
TMC Acquisitions LLC dba Tailor Made Compounding · Nicholasville, KY
1 recall
- Class II, terminated, reported Aug 30, 2023: Lack of Assurance of SterilityD-1105-2023 · Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.
Pharmacy Plus, Inc. dba Vital Care Compounder · Hattiesburg, MS
2 recalls
- Class II, ongoing, reported Apr 26, 2023: Lack of assurance of sterility.D-0538-2023 · C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder 115 South 40th Ave, Suite A Hattiesburg, MS 39402
- Class II, ongoing, reported Nov 9, 2022: 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.D-0053-2023 · SEMAGLUTIDE INJECTION 5MG/ML (0.25MG/0.05ML) SOLN, various amounts in unit dose vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hat...
Pharmacy Innovations · Erie, PA
1 recall
- Class II, terminated, reported Feb 1, 2023: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.D-0236-2023 · SEMAGLUTIDE 0.5MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 1MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 2MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTI...
Carolina Infusion · Ridgeland, SC
3 recalls
- Class II, completed, reported Sep 21, 2022: Lack of Assurance of Sterility
3 products recalled
- D-1519-2022 · Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
- D-1520-2022 · Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
- D-1521-2022 · Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
TMC Acquisition LLC dba Tailor Made Compounding · Nicholasville, KY
2 recalls
- Class II, ongoing, reported Jul 20, 2022: Lack of Assurance of Sterility
2 products recalled
- D-1224-2022 · Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made Compounding
- D-1225-2022 · Semaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made Compounding
Novo Nordisk Inc · Plainsboro, NJ
4 recalls
- Class II, terminated, reported Apr 21, 2021: 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 the cartridge and pen-injectors.
3 products recalled
- D-0617-2021 · OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample. Not for Resale, Rx only, Novo Nordisk Inc, Plainsbor...
- D-0618-2021 · Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample. Not for Resale., Rx only, Novo Nordisk Inc., Plainsbo...
- D-0622-2021 · ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pen, Sample Not for Resale, Rx only, Manufactured by: Novo Nordis...
- Class I, terminated, reported Apr 21, 2021: 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 the cartridge and pen-injectors.D-0623-2021 · Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL and 3.6 mg/mL, 3 mL Prefilled Pen, SAMPLE, Rx only, Manufactured...
How this list is built
- A daily job reads FDA’s drug enforcement reports through openFDA, keeps every report whose product description names semaglutide, tirzepatide or liraglutide, and rewrites this list only when FDA’s data changes.
- The date at the top is FDA’s own update date, not the day our job ran.
- Firm, class, status, dates, product and reason are copied from FDA’s records. Firms are linked to their 503B register entry only when the names match exactly.
- Source: FDA enforcement reports ↗. See also FDA warning letters naming GLP-1 drugs.