Sodium Monobasic recalls

The FDA has published 2 recalls involving Sodium Monobasic since 2013. The latest was reported on 10 Dec 2025. Most were for sterility. Blossom Pharmaceuticals 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 recalls2since 2013

Last 12 months1reported

Class I00% of total

Ongoing1latest 10 Dec 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 1 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why sodium monobasic is recalled

Sterility150%
Manufacturing (CGMP) Deviations150%

Companies

By year

2025150%
2013150%

Ongoing sodium monobasic recalls

1 active

Reported	Class	Recall	Company	Reason	Where
10 Dec 2025Drug	CLASS II	Wecare Enema recalled by Blossom PharmaceuticalsSaline Enema	Blossom Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide

All sodium monobasic recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
10 Dec 2025Drug	CLASS II	Wecare Enema recalled by Blossom PharmaceuticalsSaline Enema	Blossom Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
18 Sep 2013Drug	CLASS II	Sodium Phosphate Monobasic/Water For Injection recalled	Beacon Hill Medical Pharmacy, P.C	Sterility	Nationwide

Should you stop taking Sodium Monobasic?

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.