Class II · Moderate risk
DOBUTamine Injection
Discoloration; discolored solution from cracked vials
Is Dobutamine recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Dobutamine (9 total). Check the affected lots below.
Most common reason: Sterility / contamination (5 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Dobutamine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Dobutamine recalls on record
none so far in 2026; 9 on record, newest first
Class II · Moderate risk
Dobutamine
Lack of sterility assurance
Class II · Moderate risk
DOBUTamine Injection
Discoloration: Firm received complaints of product discoloration and particulates.
Class II · Moderate risk
Dobutamine 2000 mcg/mL in a) D5W-500 mL
Lack of Sterility Assurance.
Class II · Moderate risk
DOBUTAMINE HCL in D5W
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Dobutamine various strengths in dextrose
Lack of sterility assurance.
Class II · Moderate risk
Dobutamine Hydrochloride active pharmaceutical ingredient…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class I · High risk
DOBUTamine Injection
Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution.
Class II · Moderate risk
DOBUTamine in 5% Dextrose Injection
Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
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