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WARNING LETTER
•DK Hardware Supply•March 1, 2026

DK Hardware Supply – FDA Warning Letter, Mar 1, 2026

Record Details

On April 3, 2026, the FDA issued a warning letter to DK Hardware Supply following a March 2026 review of the company"s website. The agency found that the firm is distributing several antimicrobial drugs for aquarium fish—including Amoxicillin, Penicillin, and Ciprofloxacin—that have not undergone the required federal approval process. Under the Federal Food, Drug, and Cosmetic Act, these products are classified as unapproved new animal drugs and are considered misbranded because they were not properly listed with the FDA, nor were they manufactured in registered facilities. The FDA highlighted a significant public health concern regarding the over-the-counter sale of these medications. Because these antibiotics are medically important to human medicine, their use without the supervision of a licensed veterinarian contributes to the growing threat of antimicrobial resistance. To comply with the law, medications for minor species like aquarium fish must be officially approved, conditionally approved, or included on the FDA’s specific index for legal marketing. DK Hardware Supply is required to respond to the FDA within 15 business days to outline the specific steps taken to correct these violations and prevent their recurrence. Failure to address these issues may result in legal action, such as product seizures or injunctions prohibiting the company from further distributing these illegal products.

Company
DK Hardware Supply
Inspection date
March 1, 2026
Product type
Drugs
Office
Division of Drug Compliance
Person
  • Dillard H. Woody Jr. (Acting Director)
View Company Profile

ID · a41b2474-b7ab-49bc-9c15-8e17739eca62

Violation Codes10
21 U.S.C. 360b(a)21 U.S.C. 360(j)FD&C Act 501(a)(5)FD&C Act 502(o)FD&C Act 510(j)(1)FD&C Act 201(v)(1)21 U.S.C. 360b21 U.S.C. 360cccFD&C Act 201(g)(1)(B)FD&C Act 301(a)

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