Sato Pharmaceutical Optic Splash Eye Drops Recall: Risk of Contamination
Sato Pharmaceutical recalls Optic Splash eye drops due to lack of sterility assurance in manufacturing. Affected lots may contain harmful bacteria. Consumers should contact the company for details.
Lower-risk recall
Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.
Contact the company
What happened, in plain English
Sato Pharmaceutical is recalling Optic: Splash eye drops that were manufactured without proper sterility checks. This could lead to bacterial contamination and eye infections if used. Read more at govinfonow.com/recall/41941-sato-pharmaceutical-optic-splash-eye-drops-recall-risk-of-contamination.
Source Summary by GovInfoNow · govinfonow.com/recall/41941-sato-pharmaceutical-optic-splash-eye-drops-recall-risk-of-contamination · Updated October 8, 2026 · FDA enforcement record: FDA #D-0854-2017
Cite this page
“Sato Pharmaceutical Optic Splash Eye Drops Recall: Risk of Contamination.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41941-sato-pharmaceutical-optic-splash-eye-drops-recall-risk-of-contamination. Based on FDA recall #D-0854-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0854-2017%22&limit=1).
Why it’s dangerous
The manufacturing process did not properly monitor environmental conditions in sterile areas, which could allow bacteria to contaminate the eye drops. This poses a risk of eye infections if the product is used.
Who’s affected
People who own or use the recalled Optic Splash eye drops. Those with compromised immune systems may be at higher risk of infection.
How to tell if you have this one
Check for the product name 'Optic Splash' on the label. The lot number is XXWC and the expiration date is August 2018. The product was manufactured by Sato Pharmaceuticals in Japan.
- Brand
Sato Pharmaceutical- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US: Hawaii, Guam, Saipan, SPI
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0854-2017 | Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-501-01.; Lot #: XXWC, Exp. August 2018 | 10,130 bottles |
| D-0855-2017 | SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-044-01; Lot #: WXWZ, Exp. March 2019; WXTS, Exp. October 2019 | 4,790 bottles |
| D-0856-2017 | DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-020-01; Lot #: WXTZ, Exp. Sep 2019 | 14,325 bottles |
What to do — step by step
Check Product Details
Look for the lot number XXWC and expiration date August 2018 on the bottle label.
Where it went and when
Where it was distributed
Distributed in Hawaii.
FDA distribution: “US: Hawaii, Guam, Saipan, SPI” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Hawaii.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0854-2017 (February 16, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0854-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.