Home / Recalls / GenoGenix LLC / D-0092-2026

D-0092-2026 Class II Ongoing

Recalled by GenoGenix LLC — Boca Raton, FL

Recall Details

Product Type
Drugs
Report Date
October 15, 2025
Initiation Date
July 30, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

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 and Synergy Wellness 60mg, 10mL vial lyophilized.

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

US Nationwide.

Code Information

Lots GG012925-005, GG021125-003, within expiry.

Other recalls by GenoGenix LLC

  • D-0064-2026 Class II — N-Acetyl-L-Cysteine for Injection, all strengths and presentations, GenoGenix, L (July 30, 2025)
  • D-0065-2026 Class II — NAD+ (Nicotinamide adenine dinucleotide), a) 50 mg/mL, b) 100 mg/mL, 10 mL multi (July 30, 2025)
  • D-0066-2026 Class II — Taurine for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW (July 30, 2025)
  • D-0038-2026 Class II — Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, LLC (July 30, 2025)
  • D-0079-2026 Class II — Proline for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW (July 30, 2025)
  • D-0074-2026 Class II — Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths and (July 30, 2025)
  • D-0043-2026 Class II — B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, L (July 30, 2025)
  • D-0089-2026 Class II — Epithalon for Injection, 20mg, all presentations, GenoGenix, LLC, 2840 NW 2nd Av (July 30, 2025)
  • D-0060-2026 Class II — Lipo MIC +B12 Methylcobalamin for Injection, all strengths and presentations, Ge (July 30, 2025)
  • D-0082-2026 Class II — Sterile Saline Reconstitution Solution for Injection, all strengths and presenta (July 30, 2025)