Lidocaine Hydrochloride Injection Recalled for Sterility Assurance
Asclemed USA Inc. is recalling Lidocaine Hydrochloride Injection USP, 1% (10 mg/mL) in 5 mL single dose ampules nationwide due to lack of assurance of sterility. The affected lots have expiration dates of 11/30/2026 and 04/30/2028.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a sterility assurance defect in an injectable drug product. Lack of sterility in parenteral medications poses a serious risk of infection and is grounds for a Severe classification under the rubric criterion for Class II recalls with significant health risk potential.
Plain-English summary
Asclemed USA Inc. is recalling Lidocaine Hydrochloride Injection USP, 1% (10 mg/mL), distributed in 5 mL single dose ampules under NDC 85766-187-01. The product is distributed nationwide by Enovachem Pharmaceuticals. The recall is due to lack of assurance of sterility for the affected lots.
The recalled lots include: AE3102 (Lot # 031926L01, 032026A01, Exp 11/30/2026) and AE5052 (Lot # 052026G01, Exp 04/30/2028). These are prescription-only products used for epidural, infiltration, intracaudal, and perineural injection.
Patients and healthcare providers with these products should contact Asclemed USA Inc. or their pharmacy to determine if they have received affected units. Healthcare facilities should review their inventory and quarantine any affected lots pending further guidance from the FDA or the manufacturer.
The recalled product
- Product
- LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE ANHYDROUS)
- Brand
- LIDOCAINE HYDROCHLORIDE
- Manufacturer
- Asclemed USA Inc.
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 (7)
- Lot #: AE3102
- 031926L01
- 032026A01
- Exp 11/30/2026
- AE5052
- 052026G01
- Exp 04/30/2028.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Asclemed USA Inc. 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.
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