Why it was recalled
Lack of Assurance of Sterility
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 numbers, UPCs & expiration codes
Lot #: AE3102, 031926L01, 032026A01, Exp 11/30/2026; AE5052, 052026G01, Exp 04/30/2028.
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0659-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 8, 2026
- FDA report date
- Jul 8, 2026
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Asclemed USA Inc.
Original FDA data
Every field from FDA enforcement report D-0659-2026, exactly as published.
Show all FDA fields
- City
- Torrance
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 99204
- Address
- 379 Van Ness Ave Ste 1403
- Code information
- Lot #: AE3102, 031926L01, 032026A01, Exp 11/30/2026; AE5052, 052026G01, Exp 04/30/2028.
- Postal code
- 90501-7211
- Report date
- Jul 8, 2026
- Product type
- Drugs
- Recall number
- D-0659-2026
- Classification
- Class II
- Recalling firm
- Asclemed USA Inc.
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jun 8, 2026
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jul 2, 2026