The Recall Registry
Recall data checked 5 hours ago

Home Prescription medicine Denver Solutions, LLC DBA Leiters Health —…

Food & drug recall · FDAMarch 31, 2025Serious

Denver Solutions, LLC DBA Leiters Health — 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

Do not stop taking this without speaking to your pharmacist or doctor.

What’s wrong

Lack of Assurance of Sterility: Leaking/damaged syringes.

The Recall Registry rates this seriousFDA Class II: temporary or medically reversible health harm.

What to do

Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.

Who to contact: Recalling firm: Denver Solutions, LLC DBA Leiters Health

The 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

Details

Units affected
49,830 syringes
Recall date
March 31, 2025
Brand
Denver Solutions, LLC DBA Leiters Health
Model, lot or SKU numbers
Lot #:2530019, Exp.: 7/10/20252530053, Exp.: 7/19/2025.
Where it was distributed

Nationwide in the U.S.A

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: Denver Solutions, LLC DBA Leiters Health — 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

Read it on FDA

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Prescription medicine

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