The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0897-2023·Announced 2023-07-19

Sunmark and Generic Eye Drops Recalled for Manufacturing Deficiency

K.C. Pharmaceuticals is recalling 341,568 bottles of Sunmark and generic tetrahydrozoline eye drops due to manufacturing practice deficiencies. The recall affects multiple brands distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA classified this as a Class II recall due to manufacturing practice deficiencies that could affect product safety and quality. Although no illnesses or injuries have been reported, the CGMP deviation related to fill line documentation represents a risk-of-harm situation where manufacturing process integrity has been compromised.

Plain-English summary

K.C. Pharmaceuticals is recalling 341,568 bottles of Sunmark Eye Drops Original Formula (tetrahydrozoline HCl 0.05%, 0.5 FL OZ) and equivalent products distributed under multiple brand names nationwide, including DG Health, Publix, TopCare, GoodSense, Circle K, Lil' Drug Store, Rugby, Leader, CAREone, Good Neighbor Pharmacy, Walgreens, CVS Health, H-E-B, Meijer, and Best Choice.

The recall is due to good manufacturing practice (CGMP) deficiencies related to a lack of documentation of the fill line, which is essential to manufacturing process control and product quality assurance.

The affected lots are RG21F01, RG21F02, and RG21F03, all with an expiration date of June 30, 2023. Multiple UPCs and NDCs are affected across the various distributor and retailer versions of this product.

The recalled product

Product
SUNMARK EYE DROPS ORIGINAL FORMULA (TETRAHYDROZOLINE HCL)
Brand
SUNMARK EYE DROPS ORIGINAL FORMULA
Manufacturer
K.C. Pharmaceuticals, Inc
Category
Drug — Ophthalmic
Hazard
Affected units
341,568

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 #: a) RG21F01
  • Exp: 6/30/2023
  • b) RG21F01
  • c) RG21F01
  • d) RG21F01
  • RG21F02
  • Exp 6/30/2023
  • e) RG21F02
  • RG21F03
  • f) RG21F02
  • g) RG21F02
  • h) RG21F02
  • i) RG21F02
  • j) RG21F02
  • k) RG21F02
  • l) RG21F02
  • m) RG21F03
  • n) RG21F03
  • o) RG21F03
  • p) RG21F03

UPCs (19)

  • 0010939167330
  • 0180410000156
  • 0041250829164
  • 095072005565
  • 041415010765
  • 010939167330
  • 036800036390
  • 180410000156
  • 194283651858
  • 366715683243
  • 305361217945
  • 096295136456
  • 041520865311
  • 087701149757
  • 311917200767
  • 050428361313
  • 041220437474
  • 041250829164
  • 070038470113

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by K.C. Pharmaceuticals, Inc 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 2 products in this recall →

Related recalls

Same brand · SUNMARK EYE DROPS ORIGINAL FORMULA

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