Marcaine 0.25%
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Yes — there is an active recall. 5 ongoing FDA recalls mention Bupivacaine (306 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Bupivacaine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
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