FDA recall, , Moderate risk
Enovachem Pharmaceuticals Lidocaine HCl Injection
Accucaine kits containing Lidocaine HCl Injection lack assurance of sterility.
Summary by Recall Canary from the FDA notice
What happened
Asclemed USA Inc., of Torrance, California, began a recall of Accucaine Kit and Lidocaine HCl Injection USP on June 8, 2026, because of a lack of assurance of sterility. The products were distributed nationwide in the USA. The FDA added the recall to its Enforcement Report and classified it on July 2, 2026, with the recall in the weekly enforcement report on July 8, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your kit affected?
2 products
Match the lot code and NDC listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (
- Strength
- 10 mg/mL
- NDC
- 76420-715-01
- Lot code
- AE3102
- 121924X2
- 022525X4
- 033125X1
- 030426X2
- 033125X2
- 041725X3
- 061225X1
- 072225X3
- 080525X6
- 080525X7
- 080525X8
- 091225X1
- 100225X2
- 100625X1
- 122225X4
- 010626X3
- 041326X4
Lidocaine HCl Injection USP, 1% (
- Strength
- 10 mg/mL
- NDC
- 85766-187-01
- Lot code
- AE3102
- 031926L01
- 032026A01
Recall details
- Company began the recall
- Sold in
USA Nationwide
- Company
- Asclemed USA Inc.Torrance, California
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99204
- Recall numbers
- D-0658-2026 to D-0659-2026
All recalls from Asclemed USA Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
