Accucaine Lidocaine Injection Recalled for Lack of Sterility Assurance
Asclemed USA Inc. is recalling specific lots of Accucaine (Lidocaine HCl Injection USP, 1%) distributed nationwide due to lack of assurance of sterility. The affected product is distributed by Enovachem Pharmaceuticals.
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: This is an FDA Class II recall of a sterile injectable pharmaceutical product. Lack of assurance of sterility in injectable medications poses a significant risk of infection and other serious adverse health consequences, meeting the Severe classification criterion.
Plain-English summary
Asclemed USA Inc. is recalling specific lots of Accucaine (Lidocaine HCl Injection USP, 1%, 5 mL single dose ampules, NDC 76420-715-01) distributed nationwide because the manufacturer cannot assure the sterility of the product.
The affected lots are: AE3102 (expiration 11/30/2026) with lot codes 121924X2, 022525X4, 033125X1, 030426X2, 033125X2, 041725X3, 061225X1, 072225X3, 080525X6, 080525X7, 080525X8, 091225X1, 100225X2, 100625X1, 122225X4, and 010626X3, 041326X4; and lot AE5052 (expiration 04/30/2028) with lot codes 041426X2, 041726X1, 051826X2.
Accucaine is a prescription local anesthetic distributed by Enovachem Pharmaceuticals, Torrance, CA 90501. Healthcare providers and patients who have this product should stop using it and contact their healthcare provider for guidance. Patients should not use recalled product and should return it to the pharmacy or healthcare facility where it was dispensed.
The recalled product
- Product
- ACCUCAINE (LIDOCAINE HYDROCHLORIDE)
- Brand
- ACCUCAINE
- 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 (20)
- Lot #: AE3102
- 121924X2
- 022525X4
- 033125X1
- 030426X2
- 033125X2
- 041725X3
- 061225X1
- 072225X3
- 080525X6
- 080525X7
- 080525X8
- 091225X1
- 100225X2
- 100625X1
- 122225X4
- 010626X3
- 041326X4
- Exp 11/30/2026
- AE5052
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.
See all 2 products in this recall →Related recalls
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