Ketamine HCl 50mg per 5mL (10 mg per mL) recall
FDA recall D-0373-2025 · initiated Mar 31, 2025
Denver Solutions, LLC DBA Leiters Health recalled Ketamine HCl 50mg per 5mL (10 mg per mL) in Mar 2025 — an FDA Class II recall (D-0373-2025) because Lack of Assurance of Sterility: Leaking/damaged syringes.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: Leaking/damaged syringes.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 49,830 syringes
Details
- 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 company
- Denver Solutions, LLC DBA Leiters Health
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the U.S.A
- Initiated
- Mar 31, 2025
- FDA report date
- Apr 30, 2025
Frequently asked
- Was Ketamine HCl 50mg per 5mL (10 mg per mL) recalled?
- Denver Solutions, LLC DBA Leiters Health recalled Ketamine HCl 50mg per 5mL (10 mg per mL) in Mar 2025 — an FDA Class II recall (D-0373-2025) because Lack of Assurance of Sterility: Leaking/damaged syringes. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Ketamine HCl 50mg per 5mL (10 mg per mL) recalled?
- Per the FDA enforcement record, the reason for recall D-0373-2025 was: Lack of Assurance of Sterility: Leaking/damaged syringes.
- Is a recalled Ketamine HCl 50mg per 5mL (10 mg per mL) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Ketamine HCl 50mg per 5mL (10 mg per mL) are affected?
- Distributed: Nationwide in the U.S.A. The recall covers these lots — Lot #:2530019, Exp.: 7/10/2025; 2530053, Exp.: 7/19/2025.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0373-2025.