Sterile Water recalls

The FDA has published 6 recalls involving Sterile Water since 2014. The latest was reported on 8 Mar 2023. Most were for sterility. Nephron Sc 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 recalls6since 2014

Last 12 months0reported

Class I00% of total

Ongoing0latest 8 Mar 2023

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 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 6 100%Class III 0 0%

Why sterile water is recalled

Sterility583%
Foreign Material117%

Companies

By year

2023233%
2019117%
2017117%
2014233%

All sterile water recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
8 Mar 2023Drug	CLASS II	Sterile Water for Injection, USP, mL Single-Dose Vials recalledSterile Water	Nephron Sc	Sterility	SC
1 Feb 2023Drug	CLASS II	Sterile Water for Injection recalled by Nephron ScSterile Water	Nephron Sc	Sterility	Nationwide
14 Aug 2019Drug	CLASS II	Sterile Water For Injection USP, [10, 30, or] per Vial recalled	RXQ Compounding	Sterility	Nationwide
4 Oct 2017Drug	CLASS II	Sterile Water for Injection, USP Single Dose vials recalled by Pfizer	Pfizer	Foreign Material	Nationwide
3 Dec 2014Drug	CLASS II	Sterile Water for Injection, USP container recalled by Hospira	Hospira	Sterility	Nationwide
21 May 2014Drug	CLASS II	Sterile Water for Injection ampoules recalled by Flawless Beauty	Flawless Beauty	Sterility	Nationwide

Should you stop taking Sterile Water?

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.