Pharmedium Recalls Lidocaine HCl Due to Sterility Assurance Concerns
Pharmedium Services, LLC is recalling all lots of Lidocaine HCl due to a lack of sterility assurance. The recall covers products distributed nationwide in the U.S.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. While the specific injury reports are not detailed in the snippet, the 'lack of sterility assurance' for a drug product implies a significant risk of infection, aligning with the Severe classification for Class II drug recalls with potential for serious harm.
Plain-English summary
Pharmedium Services, LLC is voluntarily recalling Lidocaine HCl in all strengths, doses, and packaging. The recall is being conducted because of a lack of sterility assurance in the product. The affected products were distributed nationwide in the United States.
The recall includes all lots of the product that remain within their expiration dates. The source text does not specify the number of units affected or the specific dates of distribution.
Consumers and healthcare providers should stop using the recalled Lidocaine HCl products and contact their pharmacist or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Lidocaine HCl in all strengths, all doses, and all packaging.
- Manufacturer
- Pharmedium Services, LLC
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 (1)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by Pharmedium Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 42 products in this recall →Related recalls
Same manufacturer · Pharmedium Services, LLC
See all →- SeverePharMEDium Recalls nICARdipine HCl Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls ePHEDrine Sulfate Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Fentanyl Citrate Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Fentanyl Citrate Infusions Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
- SeverePharMEDium Recalls Rocuronium Bromide Syringes Due to Sterility Assurance Issues
FDA (Drugs) · 2020-04-15
Same hazard · infection
See all →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
Similar recalls
- HighLidocaine Injectable Solution Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2023-05-31
- SevereGreen Valley Drugs Recalls Lidocaine Injections Due to Sterility Concerns
FDA (Drugs) · 2013-05-22
- SeverePharmedium Recalls Lidocaine HCl Syringes Due to Stability Data Concerns
FDA (Drugs) · 2016-10-19
- SeverePharmedium Recalls Lidocaine Syringes Due to Stability Data Concerns
FDA (Drugs) · 2016-10-19
- ModeratePharMEDium Lidocaine Syringes Recalled for Potential Loss of Potency
FDA (Drugs) · 2016-10-19
- HighLidocaine HCl Injection Recall Due to Lack of Sterility Assurance
FDA (Drugs) · 2024-08-28