Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
50 recalls
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Class II Ongoing
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 19341. NDC: 84139-225-04
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- 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 19341. NDC: 84139-225-04
- Lots / codes
- Lot, Best Use Date (BUD): Lot PRORX050925-1, BUD November 4, 2025; Lot ProRx051425-5, BUD November 10, 2025; Lot ProRx051425-6, BUD November 10, 2025
- Distribution
- TX and UT
- Quantity
- 8,400 vials
- Recall started
- October 15, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0115-2026
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Class II Ongoing
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 19341. NDC: 84139-225-09
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- 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 19341. NDC: 84139-225-09
- Lots / codes
- Lot# Prorx04282025-3
- Distribution
- TX and UT
- Quantity
- 2,809 vials
- Recall started
- October 15, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0114-2026
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Class II Ongoing
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. Also labeled as manufactured for Synergy Wellness, 20 mg, 10mL vial lyophilized.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot#: GG021125-001, GG031125-017, within expiry.
- Distribution
- US Nationwide.
- Quantity
- —
- Recall started
- July 30, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0091-2026
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Class II Ongoing
Semaglutide with B12 for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- All lots within expiry.
- Distribution
- US Nationwide.
- Quantity
- —
- Recall started
- July 30, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0083-2026
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Class II Ongoing
Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy
Reason: Subpotent Drug
Lots, distribution and details
- Lots / codes
- 03202025@2, 03202025@3 and 03202025@4 BUD 07/18/2025
- Distribution
- U.S. Nationwide
- Quantity
- 648 vials
- Recall started
- July 9, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0609-2025
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Class II Ongoing
Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy
Reason: Subpotent Drug
Lots, distribution and details
- Lots / codes
- 03202025@9 BUD 07/18/2025
- Distribution
- U.S. Nationwide
- Quantity
- 186 vials
- Recall started
- July 9, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0608-2025
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Class II Ongoing
Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy
Reason: Subpotent Drug
Lots, distribution and details
- Lots / codes
- 03202025@5, 03202025@6, 03202025@7, 03202025@8 BUD 07/18/2025
- Distribution
- U.S. Nationwide
- Quantity
- 642 vials
- Recall started
- July 9, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0606-2025
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Class II Ongoing
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 Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Reason: Lack of Processing Controls.
Lots, distribution and details
- Lots / codes
- All Lots within expiry.
- Distribution
- MA
- Quantity
- 158 vials
- Recall started
- July 18, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0565-2025
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Class II Ongoing
Semaglutide + 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, Kirkl…
Reason: Lack of Processing Controls.
Lots, distribution and details
- Product
- Semaglutide + 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.
- Lots / codes
- All Lots within expiry.
- Distribution
- MA
- Quantity
- 176 vials
- Recall started
- July 18, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0564-2025
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Class II Ongoing
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 Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Reason: Lack of Processing Controls.
Lots, distribution and details
- Lots / codes
- All Lots within expiry.
- Distribution
- MA
- Quantity
- 190 vials
- Recall started
- July 18, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0563-2025
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Class II Ongoing
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 Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Reason: Lack of Processing Controls.
Lots, distribution and details
- Lots / codes
- All Lots within expiry.
- Distribution
- MA
- Quantity
- 194 vials
- Recall started
- July 18, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0562-2025
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Class II Ongoing
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 Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Reason: Lack of Processing Controls.
Lots, distribution and details
- Product
- 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 Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
- Lots / codes
- All Lots within expiry.
- Distribution
- MA
- Quantity
- 221 vials
- Recall started
- July 18, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0561-2025
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Class II Ongoing
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, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Reason: Lack of Processing Controls.
Lots, distribution and details
- Lots / codes
- All Lots within expiry
- Distribution
- MA
- Quantity
- 290 vials
- Recall started
- July 18, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0553-2025
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Class II Ongoing
Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot: C03075J, Ex p 7/7/2025
- Distribution
- USA Nationwide
- Quantity
- 28 syringes
- Recall started
- May 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0481-2025
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Class II Ongoing
Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- 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
- Distribution
- USA Nationwide
- Quantity
- 164 syringes
- Recall started
- May 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0480-2025
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Class II Ongoing
Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, CO 80112
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: H270221, Exp 12/26/2025
- Distribution
- USA Nationwide
- Quantity
- 32 syringes
- Recall started
- May 21, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0479-2025
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Class II Ongoing
Wegovy (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, D…
Reason: 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.
Lots, distribution and details
- Product
- Wegovy (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.
- Lots / codes
- Lot PZFDE06, Exp 08/31/2025
- Distribution
- NC, SC, VA
- Quantity
- 48 Cartons
- Recall started
- April 9, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0393-2025
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Class II Ongoing
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
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- 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
- Lots / codes
- Lot # ProRx031924-1, BUD 09/18/2024
- Distribution
- Nationwide in the USA
- Quantity
- 500 vials
- Recall started
- August 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0654-2024
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Class II Ongoing
SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- ProRx061424, BUD 12/13/2024
- Distribution
- Nationwide in the USA
- Quantity
- 1,960 vials
- Recall started
- August 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0653-2024
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Class II Ongoing
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
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Lot #: ProRx052424, BUD 11/23/2024 ProRx060724, BUD 12/06/2024 ProRx061124, BUD 12/10/2024 ProRx061924, BUD 12/18/2024
- Distribution
- Nationwide in the USA
- Quantity
- 8,396 vials
- Recall started
- August 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0652-2024
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Class II Ongoing
Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01
- Lots / codes
- Lot #: ProRx031924, BUD 09/18/2024 ProRx032624, BUD 09/25/2024 ProRx041324, BUD 10/12/2024
- Distribution
- Nationwide in the USA
- Quantity
- 2,490 vials
- Recall started
- August 22, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0650-2024
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Class II Ongoing
C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder 115 South 40th Ave, Suite A Hattiesburg, MS 39402
Reason: Lack of assurance of sterility.
Lots, distribution and details
- Product
- C-Semaglutide 5mg/mL injection, 0.5mL vials, Rx only, Vital Care Compounder 115 South 40th Ave, Suite A Hattiesburg, MS 39402
- Lots / codes
- Lot #: 73810, Exp. Date 5/1/2023
- Distribution
- MS only
- Quantity
- 45 vials
- Recall started
- April 13, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0538-2023
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Class II Ongoing
SEMAGLUTIDE 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 39402
Reason: 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.
Lots, distribution and details
- Product
- SEMAGLUTIDE 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 39402
- Lots / codes
- Lots: 65680, BUD: 10/11/2022; 66043, BUD: 10/15/2022; 66372, BUD: 10/23/2022; 66597, BUD: 10/29/2022
- Distribution
- AL, LA, MS, and TN
- Quantity
- 800.5 mL in unit dose vials
- Recall started
- October 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0053-2023
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Class II Ongoing
Semaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Semaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made Compounding
- Lots / codes
- Batch#: 12092115A2, Exp 3/9/2022; 12162116A2, Exp 3/16/2022; 12212106A2, Exp 3/21/2022; 01062219B, Exp 4/6/2022; 01072205A1, 01072208A1, Exp 4/7/2022; 01102203A1, Exp 4/10/2022; 01132207A1, Exp 4/13/2022; 01192216A1, Exp 4/19/2022; 01202204A2, Exp 4/20/2022; 01272223A2, Exp 4/27/2022; 01312219A2, Exp 5/1/2022; 02032204A2, Exp 5/4/2022; 02072203A1, Exp 5/8/2022; 02182216A1, 02182224A1, Exp 5/19/2022; 02232202A1, 02232210A1, Exp 5/24/2022; 02242202A1, 02242203A1, 02242235A1, 02242238A1, Exp 5/25/2022; 03072217A1, 03072223A1, Exp 6/5/2022; 03082223A1, 03082229A1, Exp 6/6/2022; 03092207A1, 03092219A1, Exp 6/7/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 9,993 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1225-2022
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Class II Ongoing
Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Semaglutide/Cyanocobalamin 2mg/0.4mg/ml, 1mL-vial, Refrigerate, Tailor Made Compounding
- Lots / codes
- Batch#: 12032123A2, Exp 3/3/2022; 12102101A2, Exp 3/10/2022; 12202105A2, Exp 3/20/2022; 12292106A2, Exp 3/29/2022; 01062218B, Exp 4/6/2022; 01192228A2, Exp 4/19/2022; 01312214A2, Exp 5/1/2022; 02012211A1, Exp 5/2/2022; 02182201A1, 02182203A1, Exp 5/19/2022; 02242205A1, 02242206A1, Exp 5/25/2022; 03072209A1, Exp 6/5/2022; 03092203A1, 03092206A1, Exp 6/7/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 5,842 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1224-2022
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.