The Recall Desk
HighFDA (Drugs)·D-0776-2022·Announced 2022-04-27

Injectable Drug Recalled for Sterility Concerns Due to Manufacturing Defects

North American Custom Laboratories recalls BPC-157 injectable solution due to manufacturing deviations that compromise sterility assurance. The FDA classified this as a Class II recall affecting 778 vials distributed nationwide.

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 injectable drug recall is scored as High (3) because it involves sterility concerns for a parenteral product, constituting a risk-of-harm scenario. However, no illnesses or injuries have been reported, and the hazard remains theoretical rather than confirmed through adverse events.

Plain-English summary

BPC-157 2 mg/mL (5 mL) Injectable Solution, sold in 5 mL vials under prescription only, has been recalled by North American Custom Laboratories, LLC (dba FarmaKeio Superior Custom Compounding) located in Richardson, Texas. The recall stems from manufacturing deviations from Current Good Manufacturing Practices (CGMP) that create uncertainty about the sterility of the product. Sterile injectable products require rigorous manufacturing controls; deviations from these standards pose a potential risk to patient safety.

The recall affects 778 vials with Lot #32242 (BUD 4/19/2022) and Lot #33911 (BUD 6/8/2022). The product was distributed nationwide within the United States. The FDA classified this recall as Class II.

If you have received this product, do not use it. Contact your healthcare provider or pharmacist for guidance on safe disposal. Report any adverse effects associated with this product to the FDA's MedWatch program or contact the manufacturer.

The recalled product

Product
BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
Manufacturer
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
Category
Drug — Parenteral / Injectable
Hazard
  • sterility-defect
  • manufacturing-defect

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 (2)

  • Lot #: 32242 BUD: 4/19/2022
  • 33911 BUD: 6/8/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category