CLASS I Drug recall · Reported 28 Dec 2016 · FDA Enforcement Report
Honeywell eyesaline Eyewash Sterile Isotonic Solution recalled
Sperian Eye & Face Protection is recalling Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, Sperian Eye &, distributed nationwide in the US. The recall was initiated on 16 Aug 2016 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0216-2017
- FDA event ID
- 74878
- Recalling firm
- Sperian Eye & Face Protection, Platteville, WI
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 16 Aug 2016
- FDA classified
- 22 Dec 2016
- Reported
- 28 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
Timeline
| 16 Aug 2016 | Recall initiated by company | |
| 22 Dec 2016 | Classified by FDA | +128 days |
| 28 Dec 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non Sterility; contaminated with Klebsiella pneumoniae
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Honeywell Company), Platteville, WI 53818
Where it was distributed
Nationwide. Outside the US to include: Australia, Mexico and United Arab Emirates.
Questions about this recall
Why was it recalled?
Non Sterility; contaminated with Klebsiella pneumoniae
Which lots are affected?
Lot number: F16091-61, exp 03/2019 Product Codes: 32-000455-0000-H5, 32-000455-0036, 32-000461-0036, 32-000462-0000-H5, 32-000462-0036
Where was it sold?
Nationwide. Outside the US to include: Australia, Mexico and United Arab Emirates.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.