Xylocaine Lidocaine Injection Recalled for Low Epinephrine Assay Results
Fresenius Kabi USA LLC is recalling Xylocaine-MPF with Epinephrine 1:200,000 injection vials nationwide due to low out-of-specification results for epinephrine assay.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source states only that epinephrine assay results were "low out of specification" with no reported illnesses, injuries, or deaths. This is a pharmaceutical quality issue without evidence of harm.
Plain-English summary
Fresenius Kabi USA LLC is recalling Xylocaine-MPF with Epinephrine 1:200,000 (Lidocaine HCl and Epinephrine Injection, USP) 1%, 300 mg/30 mL, 30 mL single-dose vials due to low out-of-specification results for epinephrine assay. The affected product consists of 234,800 vials distributed nationwide in the USA.
The affected lots are: Batch 6123435 (expiration 01/2022), Batch 6124730 (expiration 07/2022), and Batch 6124731 (expiration 07/2022). Healthcare providers and patients who have received this product should consult with their healthcare provider regarding their use of the recalled vials.
Consumers and healthcare facilities with these vials should stop use and contact Fresenius Kabi USA LLC or the FDA for further instructions on return or disposal of the affected product.
The recalled product
- Product
- XYLOCAINE (LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE)
- Brand
- XYLOCAINE
- Manufacturer
- Fresenius Kabi USA LLC
- Hazard
- out-of-specification-potency
- subpotent-epinephrine
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 (6)
- Batch
- expiry: Batch 6123435
- exp 01/2022
- 6124730
- 6124731
- exp 07/2022
UPCs (14)
- 0363323484576
- 0363323485016
- 0363323483036
- 0363323487072
- 0363323486013
- 0363323495091
- 0363323488079
- 0363323489021
- 0363323495046
- 0363323491017
- 0363323492045
- 0363323492090
- 0363323482015
- 0363323481018
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · XYLOCAINE
- HighDental anesthetic injection recalled for defective cartridge containers
FDA (Drugs) · 2025-12-24
- HighXylocaine Lidocaine Injectable Anesthetic Recalled for Storage Temperature Abuse
FDA (Drugs) · 2022-06-15
- HighXylocaine injectable anesthetic recalled for temperature abuse during manufacturing
FDA (Drugs) · 2022-06-15
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27