Multi-event September 2026 FDA Recall Drug by Insight Pharmaceuticals Llc, A Prestige Consumer Healthcare Company
This Multi-event Class II drug recall was voluntarily initiated by Insight Pharmaceuticals Llc, A Prestige Consumer Healthcare Company on September 15, 2026 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0871-2026
Lack of Assurance of Sterility
09-15-2026
09-30-2026
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) with Hang Tag, 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products Inc., Tarrytown, NY 10591. NDC: 67172-797-15
Batch or Lot Expiration Information
Lot# : RL25G04, Exp. Date 07/2027; RL2H02, Exp. Date 08/2027.
Recall Number: D-0870-2026
Lack of Assurance of Sterility
09-15-2026
09-30-2026
2,356,248 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%) , 0.5 fl oz (15mL) per dropper bottle, STERILE, Dist. by Medtech Products Inc., Tarrytown, NY 10591. NDC: 67172-797-15
Batch or Lot Expiration Information
Lot# : RL25G02, RL25G03, RL25G04, Exp. Date Jul-27; RL25H02, RL25H03, RL25H04, Exp. Date Aug-27; RL25K01, RL25K02, RL25K03, RL25K04, Exp. Date Sep-27; RL25M01, RL25M02, RL25M03, RL25M04, Exp. Date Oct-27; RL25N01, RL25N02, RL25N04, Exp. Date Nov-27.
