FDAClass IIApril 30, 2025

Ketamine HCl 50mg per recall: Sterility Concern

Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11

Why was Ketamine HCl 50mg per recalled?

Lack of Assurance of Sterility: Leaking/damaged syringes.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #:2530019, Exp.: 7/10/2025; 2530053, Exp.: 7/19/2025.

Product
Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11
Recalling firm
Denver Solutions, LLC DBA Leiters Health
Quantity
49,830 syringes
Distribution
Nationwide in the U.S.A
Recall date
April 30, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls