The Recall Desk
HighFDA (Drugs)·D-0085-2026·Announced 2025-10-15

BPC-157 Injection Recalled for Lack of Sterility Assurance

GenoGenix LLC is recalling BPC-157 for Injection nationwide due to lack of assurance of sterility in the manufacturing process. The product may contain microbial contamination, posing a risk to patients receiving injections.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of an injectable pharmaceutical with a manufacturing defect affecting sterility assurance. While no illnesses have been reported, sterility failure in parenteral products represents a high-risk condition for potential serious infection due to direct bloodstream or tissue exposure. Per the rubric, risk-of-harm products where injury has not yet been reported score as High.

Plain-English summary

BPC-157 for Injection, 15mg/10mL vials manufactured by GenoGenix LLC, is being recalled nationwide due to lack of assurance of sterility. The manufacturer cannot guarantee that manufacturing processes maintained the sterile conditions required for injectable medications.

The recall affects all presentations of this product, including those labeled as manufactured for Medical Health Institute (MHI), with lot number GG012825-002 that remains within expiration date. The product was distributed throughout the United States.

Patients who have received this injection should be aware of the potential for microbial contamination and associated infection risk. Anyone who has received or possesses this product should discontinue use and consult their healthcare provider for evaluation and guidance.

Consumers with remaining doses should not use them. Healthcare providers should refer patients who received this product to appropriate follow-up care. The recalling firm is GenoGenix LLC.

The recalled product

Product
BPC-157 for Injection, 15mg/10mL vial, all presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for Medical Health Institute (MHI), 15mg, 10mL vial lyophilized.
Manufacturer
GenoGenix LLC
Category
Drug — Injectable / Sterile Pharmaceutical
Hazard
  • sterility-failure
  • bacterial-contamination-risk
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot#: GG012825-002 within expiry.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category