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HomeUSNearly 750,000 Eye Drops Recalled Over Sterility Concerns

Nearly 750,000 Eye Drops Recalled Over Sterility Concerns

The eye drop recall covers nine products, including lubricating eye drops, a hypertonic eye solution and an ointment intended for nighttime use.

WASHINGTON — Nearly 750,000 bottles and other containers of eye drops, including products sold at Walgreens, are being recalled over concerns that they may not be sterile.

Sterling Pharmaceuticals Services LLC announced the recall on Aug. 20, 2026. The Food and Drug Administration classified it as a Class II recall on Sept. 21. Nine products are included, ranging from lubricant eye drops and hypertonicity eye solution to nighttime eye ointment.

The FDA defines a Class II recall as one involving a product that could cause temporary or medically reversible health effects, or one in which the risk of serious consequences is considered remote.

Consumers should compare the product name, lot number and expiration date on their eye drops with the recall information to determine whether they have an affected product.

Eye drop recall: Nearly 750K bottles recalled over sterility concerns

The recall involves 747,859 units in total, including packs, bottles and tubes.

AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% (0.5 FL OZ / 15 mL bottle)

  • Recall No.: D-0855-2026
  • NDC: 50268-068-15
  • Distributor: AvKare, Pulaski, TN 38478
  • Lots: 3161 (exp 8/2026); 3245 (3/2027); 3260 (5/2027); 3298, 3299, 3300 (6/2027); 3301, 3302, 3305, 3306 (7/2027)
  • Quantity: 12,864 packs

Reliable-1 Laboratories Sodium Chloride Hypertonicity Ophthalmic Solution 5% (0.5 FL OZ / 15 mL bottle)

  • Recall No.: D-0856-2026
  • NDC: 69618-077-55
  • Distributor: Reliable-1 Laboratories LLC, Valley Stream, NY 11580
  • Lots: 3192 (exp 01/31/2027, as printed in the notice); 3293, 3336 (exp 06/30/2027)
  • Quantity: 11,083 bottles

Walgreens Lubricant Eye Drops, Carboxymethylcellulose Sodium 0.5% (0.5 FL OZ / 15 mL bottle)

  • Recall No.: D-0857-2026
  • NDC: 0363-8833-15
  • Distributor: Walgreen Co., Deerfield, IL 60015
  • Lots: 3166 (exp 9/2026), 3172 (exp 9/2026), plus additional lots truncated in the source list (“more…”)
  • Quantity: 301,114 bottles

Walgreens Lubricant Eye Drops, 2-Count Twin Pack (0.5 FL OZ / 15 mL each, 1.0 FL OZ / 30 mL total)

  • Recall No.: D-0858-2026
  • NDC: 0363-8833-15
  • Distributor: Walgreens Co., Deerfield, IL 60015
  • Lots: 3165 (9/2026); 3179 (10/2026); 3204, 3206, 3208 (12/2026); 3259 (4/2027); 3265 (5/2027); 3268 and others truncated in the source list
  • Quantity: 199,600 packs

Reliable-1 Laboratories Lubricating Tears (0.5 FL OZ / 15 mL bottle)

  • Recall No.: D-0859-2026
  • NDC: 69618-076-55
  • Distributor: Reliable-1 Laboratories LLC, Valley Stream, NY 11580
  • Lots: 3171 (exp 09/30/2026); 3174 (10/31/2026); 3275 (06/30/2027); 3304 (07/31/2027)
  • Quantity: 47,616 bottles

Nearly 750,000 Eye Drops Recalled Over Sterility Concerns

TRP The Relief Products Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose Sodium 0.5% (0.5 FL OZ / 15 mL bottle)

  • Recall No.: D-0860-2026
  • NDC: 17312-430-15
  • Manufactured for: TRP Company, Inc., Reno, NV 89502
  • Lots: 3279 (exp 6/30/2027); 3292 (exp 5/31/2027)

Major LubriFresh P.M. Nighttime Ointment (net wt. 0.125 oz / 3.5 g tube)

  • Recall No.: D-0861-2026
  • NDC: 0904-6488-38
  • Distributor: Major Pharmaceuticals, Livonia, MI 48152
  • Lot: 3183
  • Quantity: 34,368 tubes

Cameron Pharmaceuticals Lubricant Eye Drops, Carboxymethylcellulose Sodium 0.5% (0.5 FL OZ / 15 mL bottle)

  • Recall No.: D-0862-2026
  • NDC: 42494-448-05
  • Distributor: Cameron Pharmaceuticals, LLC, Louisville, KY 40245
  • Lots: 3163 (exp 8/31/2026); 3164 (exp 9/30/2026)
  • Quantity: 19,284 bottles

AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, 2-Count Twin Pack (0.5 FL OZ / 15 mL each, 1.0 FL OZ / 30 mL total)

  • Recall No.: D-0863-2026
  • NDC: 50268-068-02 (carton)
  • Distributor: AvKare, Pulaski, TN 38478
  • Lots: 3161 (exp 8/2026); 3245 (3/2027); 3260 (5/2027); 3298, 3299, 3300 (6/2027); 3301, 3302, 3305, 3306 (7/2027)
  • Quantity: 107,377 packs