Class II · Moderate risk
Aminophylline Injection
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Is Aminophylline recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Aminophylline (6 total). Check the affected lots below.
Most common reason: Other (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Aminophylline. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Aminophylline recalls on record
none so far in 2026; 6 on record, newest first
Class II · Moderate risk
Aminophylline 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
Aminophylline 2.5% Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Aminophylline 25mg/ml 10ml
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
Aminophylline 250mg 10ml
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
Aminophylline 20ml
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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