Medications & Supplements/Over-the-Counter

DG health, equate, and Other Eye Drops Recalled for Manufacturing Deficiencies

Agency Publication Date: July 7, 2023

Summary

K.C. Pharmaceuticals, Inc. has recalled approximately 738,998 bottles of various eye drops, including Original Redness Reliever (tetrahydrozoline HCl) and Dry Eye Relief Lubricant (glycerin, hypromellose, and polyethylene glycol). The recall was issued due to manufacturing deficiencies and a lack of proper documentation regarding the product filling line, which could affect the sterility and quality of the drops. These products were sold under numerous brand names including equate, DG health, CVS Health, Walgreens, and meijer at retail stores nationwide.

Risk

Deficiencies in the manufacturing process for sterile eye products can lead to potential contamination. Using non-sterile eye drops can cause serious eye infections, which may lead to vision impairment or other eye health complications.

What You Should Do

This recall affects multiple brands of Original Eye Drops (Redness Reliever) and Dry Eye Relief Lubricant Eye Drops, including DG health, equate, Publix, sunmark, TopCare health, GoodSense, Circle K, Lil Drug Store, Rugby, Leader, CAREone, Good Neighbor Pharmacy, Walgreens, CVS Health, H-E-B, meijer, Best Choice, HealthMart, exchange select, and GeriCare.
Check your product for lot numbers RG21F01, RG21F02, or RG21F03 with an expiration date of June 30, 2023, or lot numbers LT21FO2, LT21F02, and LT21F03 with an expiration date of June 2023. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact K.C. Pharmaceuticals, Inc. directly for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Original Eye Drops; Redness Reliever (15mL)

Variants: Tetrahydrozoline HCl 0.05%, Original Formula

UPC Codes:

095072005565

041415010765

010939167330

036800036390

180410000156

194283651858

366715683243

305361217945

096295136456

041520865311

087701149757

311917200767

050428361313

041220437474

041250829164

070038470113

Lot Numbers:

RG21F01 (Exp 6/30/2023)

RG21F02 (Exp 6/30/2023)

RG21F03 (Exp 6/30/2023)

NDC:

49348-037-29

50804-141-01

0536-1217-94

70000-0454-1

41520-431-05

24385-075-05

41250-814-01

Distributed under various store brands including DG health, Publix, sunmark, TopCare, GoodSense, Circle K, Lil Drug Store, Rugby, Leader, CAREone, Good Neighbor, Walgreens, CVS, H-E-B, meijer, and Best Choice.

Product: Dry Eye Relief Lubricant Eye Drops (15mL)

Variants: Glycerin 0.2%, Hypromellose 0.2%, Polyethylene glycol 400 1%

UPC Codes:

681131367011

095072026560

010939621443

036800361003

052569137154

614299056206

713733296922

041220437412

357896184056

Lot Numbers:

LT21FO2 (Exp 6/2023)

LT21F02 (Exp 6/2023)

LT21F03 (Exp 6/2023)

NDC:

49035-280-02

49348-037-29

41250-718-01

57896-181-05

Distributed under various store brands including equate, DG health, sunmark, TopCare, HealthMart, exchange select, meijer, H-E-B, and GeriCare.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92533

Status: Active

Manufacturer: K.C. Pharmaceuticals, Inc

Sold By: Walmart; Dollar General; Publix; McKesson; Topco Associates LLC; Geiss, Destin & Dunn, Inc.; Circle K Stores Inc.; Lil' Drug Store Products, Inc.; Rugby Laboratories; Cardinal Health; Foodhold USA, LLC; AmerisourceBergen; Walgreens; CVS Pharmacy, Inc.; H-E-B; Meijer Distribution Inc.; Valu Merchandisers, Co.; Military Exchanges; Gericare Pharmaceuticals Corp.

Manufactured In: United States

Units Affected: 2 products (341,568 bottles; 397,430 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects multiple brands of Original Eye Drops (Redness Reliever) and Dry Eye Relief Lubricant Eye Drops, including DG health, equate, Publix, sunmark, TopCare health, GoodSense, Circle K, Lil Drug Store, Rugby, Leader, CAREone, Good Neighbor Pharmacy, Walgreens, CVS Health, H-E-B, meijer, Best Choice, HealthMart, exchange select, and GeriCare.

Check your product for lot numbers RG21F01, RG21F02, or RG21F03 with an expiration date of June 30, 2023, or lot numbers LT21FO2, LT21F02, and LT21F03 with an expiration date of June 2023. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact K.C. Pharmaceuticals, Inc. directly for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Original Eye Drops; Redness Reliever (15mL)

Variants: Tetrahydrozoline HCl 0.05%, Original Formula

UPC Codes:

095072005565

041415010765

010939167330

036800036390

180410000156

194283651858

366715683243

305361217945

096295136456

041520865311

087701149757

311917200767

050428361313

041220437474

041250829164

070038470113

Lot Numbers:

RG21F01 (Exp 6/30/2023)

RG21F02 (Exp 6/30/2023)

RG21F03 (Exp 6/30/2023)

NDC:

49348-037-29

50804-141-01

0536-1217-94

70000-0454-1

41520-431-05

24385-075-05

41250-814-01

Product: Dry Eye Relief Lubricant Eye Drops (15mL)

Variants: Glycerin 0.2%, Hypromellose 0.2%, Polyethylene glycol 400 1%

UPC Codes:

681131367011

095072026560

010939621443

036800361003

052569137154

614299056206

713733296922

041220437412

357896184056

Lot Numbers:

LT21FO2 (Exp 6/2023)

LT21F02 (Exp 6/2023)

LT21F03 (Exp 6/2023)

NDC:

49035-280-02

49348-037-29

41250-718-01

57896-181-05

Distributed under various store brands including equate, DG health, sunmark, TopCare, HealthMart, exchange select, meijer, H-E-B, and GeriCare.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92533

Status: Active

Manufacturer: K.C. Pharmaceuticals, Inc

Manufactured In: United States

Units Affected: 2 products (341,568 bottles; 397,430 bottles)

Distributed To: Nationwide