[pending] ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Ster
Pending LLM rewrite. Source: FDA_DRUG D-0334-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Lack of Assurance of Sterility
The recalled product
- Product
- ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56
- Manufacturer
- Fresenius Kabi Compounding, LLC
- Category
- Drug — Drugs
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 (10)
- Lot # C274-000047883
- Exp Date: 17-Feb-26
- Lot # C274-000048515
- Exp Date: 22-Mar-26
- Lot # C274-000048679
- Exp Date: 31-Mar-26
- Lot # C274-000049119
- Exp Date: 19-Apr-26
- Lot # C274-000049282
- Exp Date: 27-Apr-26
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- SevereErythromycin Tablets Recalled for Impurity Above Acceptable Limits
FDA (Drugs) · 2026-05-27
- ModeratePrimidone Tablets Recalled Due to API Cross-Contamination
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27