Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 F...

FDA Drug Recall #D-0411-2026 — Class II — March 3, 2026

Recall Summary

Recall Number D-0411-2026
Classification Class II — Moderate risk
Date Initiated March 3, 2026
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm K.C. Pharmaceuticals, Inc
Location Pomona, CA
Product Type Drugs
Quantity 1,023,096 bottles

Product Description

Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL) bottles; a) GERI CARE, Distributed by: Gericare Pharmaceuticals Corp., Lakewood, NJ 08701, NDC 57896-181-05; b) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 36100 3; c) Rite Aid, DISTRIBUTEDBY: RITE AID, Camp Hill, PA 17011, NDC 11822-1067-2; d) LEADER DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; e) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01156 6; f) H-E-B, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; g) Foster & Thrive, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1158-1; h) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-718-01; i) DG health Sterile, DISTRIBUTED BY OLD EAST MAIN CO., GOODLETTSVILLE, TN 37072, UPC 0 95072 02656 0; j) Harris Teeter, Eye Drops, Artificial Tears, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 71303 2; k) exchange select, Manufactured for your Military Exchanges by: KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC 6 14299 05620 6; l) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 46122-605-05

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide in the US

Lot / Code Information

Lot: a) LT24E01, LT24E02, LT24E03, Exp.: 05/31/26; LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; LT24M01, LT24M02, Exp.: 10/31/26; b) LT24E03, Exp.: 05/31/26; LT24F01, Exp.:06/30/26; LT24G01, Exp.:07/31/26; LT24M02, Exp.: 10/31/26; c) LT24F01, Exp.: 06/30/26; d) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; e) LT24F01, Exp.: 06/30/26; f) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; g) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; h) LT24F01, Exp.: 06/30/26; i) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; j) LT24F01, Exp.: 06/30/26; k) LT24G01, Exp.: 07/31/26; L) LT24F01, Exp.: 06/30/26; m)

Other Recalls from K.C. Pharmaceuticals, Inc

Recall # Classification Product Date
D-0416-2026 Class II Artificial Tears Sterile Lubricant Eye Drops (p... Mar 3, 2026
D-0412-2026 Class II Ultra Lubricating Eye Drops (polyethylene 400 0... Mar 3, 2026
D-0413-2026 Class II Sterile Eye Drops ORIGINAL FORMULA (tetrahydroz... Mar 3, 2026
D-0414-2026 Class II Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0... Mar 3, 2026
D-0410-2026 Class II EYE DROPS Advanced Relief, (dextran 70 0.1%, po... Mar 3, 2026

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.