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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Category
- Drug — Parenteral / Injectable
- Affected units
- 778
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.
Part of a larger recall action
This product is one of 7 recalled by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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