Drug Recalls

Fresenius Kabi Compounding, LLC

Class II Ongoing

acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-035-56

Reason: Lack of Assurance of Sterility

D-0333-2026 February 18, 2026 Canton, MA

Advanced Pharmaceutical Technology, Inc.

Class II Ongoing

TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01

Reason: Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.

D-0258-2026 January 21, 2026 Elmsford, NY

Otsuka ICU Medical LLC

Class II Ongoing

0.9% SODIUM CHLORIDE Injection, USP, 100 mL, Rx only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990-7984-37

Reason: Lack of Assurance of Sterility: Potential for flexible container leaks.

D-0143-2026 November 5, 2025 Austin, TX

ProRx LLC

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

D-0115-2026 November 5, 2025 Exton, PA

ProRx LLC

Class II Ongoing

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 19341. NDC: 84139-225-06

Reason: Lack of Assurance of Sterility

D-0118-2026 November 5, 2025 Exton, PA

ProRx LLC

Class II Ongoing

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 19341. NDC: 84139-209-03

Reason: Lack of Assurance of Sterility

D-0120-2026 November 5, 2025 Exton, PA

ProRx LLC

Class II Ongoing

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 19341. NDC: 84139-225-09

Reason: Lack of Assurance of Sterility

D-0117-2026 November 5, 2025 Exton, PA

ProRx LLC

Class II Ongoing

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 19341. NDC: 84139-225-08

Reason: Lack of Assurance of Sterility

D-0116-2026 November 5, 2025 Exton, PA

ProRx LLC

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

D-0114-2026 November 5, 2025 Exton, PA

ProRx LLC

Class II Ongoing

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 19341. NDC: 84139-225-02

Reason: Lack of Assurance of Sterility

D-0119-2026 November 5, 2025 Exton, PA

Samsung Bioepis Co., Ltd.

Class II Ongoing

HADLIMA (adalimumab-bwwd) injection, 40mg/0.8 mL, 2 Single-dose Prefilled Syringes per carton, Rx only, Manufactured for: Organon LLC, a subsidiary of ORGANON & Co, Jersey City, NJ 07302, Manufactured...

Reason: Lack of Assurance of Sterility.

D-0099-2026 November 5, 2025 Yeonsu, N/A

Bristol-Myers Squibb Company

Class II Ongoing

Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton, NJ 08543, NDC 0003-7125-11

Reason: Lack of Assurance of Sterility.

D-0097-2026 October 29, 2025 New Brunswick, NJ

ASTRAZENECA PHARMACEUTICALS

Class II Ongoing

Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe, Rx only, Manufactured by: AstraZeneca AB, Sweden, Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850. ...

Reason: Lack of Assurance of Sterility:

D-0028-2026 October 22, 2025 Gaithersburg, MD

GenoGenix LLC

Class II Ongoing

B12 Hydroxocobalamin 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

D-0042-2026 October 15, 2025 Boca Raton, FL

GenoGenix LLC

Class II Ongoing

Ultra Burn 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

D-0068-2026 October 15, 2025 Boca Raton, FL

GenoGenix LLC

Class II Ongoing

B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as, manufactured for Synergy Wellness.

Reason: Lack of Assurance of Sterility

D-0043-2026 October 15, 2025 Boca Raton, FL

GenoGenix LLC

Class II Ongoing

Low Solubility Peptide Reconstitution Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.Also labeled as manufactured for CELIA ...

Reason: Lack of Assurance of Sterility

D-0076-2026 October 15, 2025 Boca Raton, FL

GenoGenix LLC

Class II Ongoing

Tesamorelin for Injection, 15mg, 10 mL Multi-Dose Vial, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.

Reason: Lack of Assurance of Sterility

D-0088-2026 October 15, 2025 Boca Raton, FL

GenoGenix LLC

Class II Ongoing

Alpha Lipoic Acid 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

D-0038-2026 October 15, 2025 Boca Raton, FL

GenoGenix LLC

Class II Ongoing

N-Acetyl-L-Cysteine 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

D-0064-2026 October 15, 2025 Boca Raton, FL

GenoGenix LLC

Class II Ongoing

L-Carnitine 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

D-0057-2026 October 15, 2025 Boca Raton, FL

GenoGenix LLC

Class II Ongoing

B5 Dexpanthenol 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

D-0044-2026 October 15, 2025 Boca Raton, FL

GenoGenix LLC

Class II Ongoing

B6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Synergy Wellness

Reason: Lack of Assurance of Sterility

D-0045-2026 October 15, 2025 Boca Raton, FL

GenoGenix LLC

Class II Ongoing

Zinc Sulfate 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

D-0070-2026 October 15, 2025 Boca Raton, FL

GenoGenix LLC

Class II Ongoing

Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Extension Health an...

Reason: Lack of Assurance of Sterility

D-0092-2026 October 15, 2025 Boca Raton, FL

FDA Enforcement Report