Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals,
Summary
The FDA issued a Class II for Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Di by Asclemed USA Inc.. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0659-2026
Action Date
2026-07-08
Status
Ongoing
Category
drug
Product Description
Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 85766-187-01.
Lot/Code Info: Lot #: AE3102, 031926L01, 032026A01, Exp 11/30/2026; AE5052, 052026G01, Exp 04/30/2028.
Quantity Affected: N/A
Reason for Recall
Lack of Assurance of Sterility
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-08
Company
Torrance, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 39 drug recalls issued in the same week, part of 81 drug-related FDA actions this month.
Asclemed USA Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Asclemed USA Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Asclemed USA Inc. have FDA actions?
Asclemed USA Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0659-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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