The Recall Desk
HighFDA (Drugs)·D-0722-2026·Announced 2026-07-29

Rohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility

Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling certain lots of Rohto Cooling Eye Drops because the company cannot assure the sterility of the product.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is for a lack of sterility in an ophthalmic (eye) product, which presents a high risk of harm to users.

Plain-English summary

Rohto-Mentholatum (Vietnam) Co., Ltd. is recalling Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80) due to a lack of assurance of sterility.

This recall affects multiple lots of the 0.4 FL OZ (13 mL) ophthalmic solution distributed nationwide within the United States. Affected products include various lot numbers with expiration dates ranging from September 2026 through January 2029.

Consumers should stop using the affected eye drops immediately and contact the distributor or retailer for information regarding returns or replacements.

The recalled product

Product
ROHTO (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80)
Brand
ROHTO
Manufacturer
Rohto-Mentholatum (Vietnam) Co., Ltd.
Category
Drug — Ophthalmic Solutions
Hazard
Affected units
2,910,148

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot #: 3J1V
  • Exp. Date 2026/09
  • 4A1V
  • Exp. Date 2026/12
  • 4G1V
  • 4G2V
  • Exp. Date 2027/06
  • 4I1V
  • Exp. Date 2027/08
  • 4JIV
  • Exp. Date 2027/09
  • 5A1V
  • Exp. Date 2027/12
  • 5B1V
  • Exp. Date 2028/01
  • 5F1V
  • Exp. Date 2028/05
  • 5F1VA
  • 5H1V & 5H1VA
  • Exp. Date 2028/07

UPCs (2)

  • 0310742010749
  • 310742010749

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Rohto-Mentholatum (Vietnam) Co., Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Related recalls

Same manufacturer · Rohto-Mentholatum (Vietnam) Co., Ltd.

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Same hazard · lack of sterility

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