Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Is Sulbactam recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Sulbactam (19 total). Check the affected lots below.
Most common reason: Sterility / contamination (17 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Sulbactam. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Sulbactam recalls on record
none so far in 2026; 19 on record, newest first
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin and Sulbactam for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ampicillin/Sulbactam 3GM IN NS 100ML
Lack of sterility assurance
Class I · High risk
Ampicillin and Sulbactam for Injection
Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
Class I · High risk
Ampicillin and Sulbactam for Injection 1.5 g vial
Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.
Class II · Moderate risk
Ampicillin/Sulbactam 12GM in NS
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Unasyn (ampicillin/sulbactam)
Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.