GoodSense original formula eye drops recalled over sterility assurance
GoodSense Eye Drops Original Formula, containing tetrahydrozoline hydrochloride, are being recalled for lack of assurance of sterility.
What this means for you
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: this is an FDA Class II recall of a sterile ophthalmic product whose sterility cannot be assured, with no injuries stated.
Plain-English summary
GoodSense Eye Drops Original Formula (tetrahydrozoline hydrochloride) are being recalled. About 378,144 bottles were distributed nationwide in the United States. The FDA has classified this recall as Class II.
The recall was initiated for lack of assurance of sterility.
Affected product covers lot RG24E01 (expiry 05/31/26) and lots RG24G01 and RG24G02 (expiry 07/31/26), across multiple package configurations listed in the FDA enforcement record.
Consumers and pharmacies can identify affected product by the lot numbers and expiry dates above, and may contact the recalling firm for further information.
The recalled product
- Product
- GOODSENSE EYE DROPS ORIGINAL FORMULA (TETRAHYDROZOLINE HCL)
- Brand
- GOODSENSE EYE DROPS ORIGINAL FORMULA
- Manufacturer
- K.C. Pharmaceuticals, Inc
- Category
- Drug — Ophthalmic
- Affected units
- 378,144
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) RG24E01
- Exp.: 05/31/26
- RG24G02
- Exp.: 07/31/26
- b) RG24E01
- c) RG24G02
- d) RG24E01
- RG24G01
- e) RG24E01
- f) RG24E01
- g) RG24E01
- h) RG24E01
- i) RG24E01
- j) RG24E01
- k) RG24E01
- L) RG24E01
- m) RG24E01
- n) RG24G01
- o) RG24G01
- p) RG24G02
UPCs (11)
- 0180410000156
- 311917200736
- 311917200767
- 366715683243
- 072036713025
- 041220437474
- 041163251106
- 194283651858
- 095072005565
- 036800036390
- 070038470113
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 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.
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