Class II · Moderate risk
Amikacin 450MG IN NS 45ML
Lack of sterility assurance
Is Amikacin recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Amikacin (14 total). Check the affected lots below.
Most common reason: Sterility / contamination (7 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Amikacin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Amikacin recalls on record
none so far in 2026; 14 on record, newest first
Class II · Moderate risk
Amikacin Sulfate Injection USP 1 gram/4mL
Lack of Assurance of Sterility
Class I · High risk
Amikacin Sulfate Injection
Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Class II · Moderate risk
Amikacin Sulfate Injection
CGMP Deviations
Class II · Moderate risk
Amikacin Sulfate Injection
CGMP Deviations
Class I · High risk
Amikacin Sulfate injection USP
Presence of Particulate Matter: particulate matter identified as glass in one vial.
Class II · Moderate risk
Amikacin various strength in normal saline bags
Lack of sterility assurance.
Class II · Moderate risk
Amikacin Sulfate active pharmaceutical ingredient packaged in…
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 II · Moderate risk
Amikacin Sulfate 250 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Amikacin 500mg 2ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Amikacin 250mg/ml 2ml vial
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Amikacin 250mg/ml 2ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Amikacin Injection
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Class II · Moderate risk
Amikacin P. F. 250mg/Ml Injectable 2 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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