K C Pharmaceuticals Recalls Eye Drops Due to Warehouse Storage Issues
K C Pharmaceuticals is recalling specific lots of Eye Drops Industrial Strength because the active ingredient was stored in a non-GMP compliant warehouse in Italy.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a documentation and storage compliance deviation rather than a direct contamination or injury risk.
Plain-English summary
K C Pharmaceuticals Inc is voluntarily recalling 71,904 bottles of Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL). The affected product is Lot # 3A450 with an expiration date of 01/06. The recall is due to Current Good Manufacturing Practice (CGMP) deviations where the Active Pharmaceutical Ingredient (API) used for manufacture was stored in a non-GMP compliant warehouse at S.I.M.S., Italy.
The recalled product was distributed nationwide in the U.S. and in Ontario, Canada. It was sold under several labels, including Petragon, Inc., SWIFT (Swift First Aid, Inc.), Xpect First aid (Cintas First Aid & Safety), and ZEE (ZEE MEDICAL, INC.).
Consumers should stop using the recalled product and return it to the place of purchase for a refund or contact the recalling firm for instructions.
The recalled product
- Product
- Eye Drops Industrial Strength (Polyethylene glycol 400 1%, Tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) Bottles, Over the Counter. Labeled: a) Manufactured for: Petragon, Inc., Edwardsville, KS 66111; b) SWIFT, Distributed by Swift First Aid, Inc., Valencia, Calif. 91355, UPC:
- Manufacturer
- K C Pharmaceuticals Inc
- Category
- Drug — Ophthalmic
- Affected units
- 71,904
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 (2)
- Lot #: 3A450
- Expiry: 01/06.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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 4 products in this recall →Related recalls
Same manufacturer · K C Pharmaceuticals Inc
See all →- HighQuality Choice moisturizing relief eye drops recalled over sterility assurance
FDA (Drugs) · 2026-04-08
- HighGNP redness and dry eye relief drops recalled over sterility assurance
FDA (Drugs) · 2026-04-08
- HighArtificial tears glycerin drops recalled over lack of sterility assurance
FDA (Drugs) · 2026-04-08
- HighLeader artificial tears 15 mL recalled over sterility assurance failure
FDA (Drugs) · 2026-04-08
- HighGoodSense original formula eye drops recalled over sterility assurance
FDA (Drugs) · 2026-04-08
Same hazard · cgmp deviation
See all →- SevereZicam Cold Remedy Nasal Swabs Recalled for Microbiological Testing Failures
FDA (Drugs) · 2026-09-02
- ModerateGolden State Medical Supply Recalls Carbamazepine Tablets Due to CGMP Deviations
FDA (Drugs) · 2026-08-26
- SevereShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19
- ModerateShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19
- HighShoolin Pharma Recalls Tadalafil USP Due to CGMP Deviations
FDA (Drugs) · 2026-08-19