Aminophylline recalls

The FDA has published 5 recalls involving Aminophylline since 2012. The latest was reported on 12 Oct 2022. Most were for sterility. Main Street Family Pharmacy has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls5since 2012

Last 12 months0reported

Class I00% of total

Ongoing1latest 12 Oct 2022

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 5 100%Class III 0 0%

Why aminophylline is recalled

Companies

Main Street Family Pharmacy240%
Pfizer120%
Lowlite Investments120%
Franck's Lab Inc., d.b.a. Franck's Compounding Lab120%

By year

2022120%
2013360%
2012120%

Ongoing aminophylline recalls

1 active

Reported	Class	Recall	Company	Reason	Where
17 Jul 2013Drug	CLASS II	Aminophylline 2.5% Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide

All aminophylline recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
12 Oct 2022Drug	CLASS II	Aminophylline Injection, USP 250 mg/ (25 mg/mL) mL Single-dose vial recalledAminophylline	Pfizer	Particulate Matter	PR
11 Dec 2013Drug	CLASS II	Aminophylline 25mg/ml, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
11 Dec 2013Drug	CLASS II	Aminophylline 250mg, Main Street Compounding Pharmacy recalled	Main Street Family Pharmacy	Other	Nationwide
17 Jul 2013Drug	CLASS II	Aminophylline 2.5% Injection recalled by Lowlite Investments	Lowlite Investments	Sterility	Nationwide
22 Aug 2012Drug	CLASS II	Aminophylline, Sdv** 500mg (25mg/ML) Injectable (1 Product) recalled	Franck's Lab Inc., d.b.a. Franck's Compounding Lab	Sterility	Nationwide

Should you stop taking Aminophylline?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.