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Class II: temporary or reversible health riskOngoing

Novocol Pharmaceutical of Canada Lidocaine HCI 2% and Epinephrine 1:100 Recall

Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP…

Novocol Pharmaceutical of Canada, Inc.

Risk level
Class II
Reported by FDA
Dec 24, 2025
Recall ID
D-0229-2026
Check your lot numberHow we source this data

Summary

Novocol Pharmaceutical of Canada recalled Lidocaine HCI 2% and Epinephrine 1:100 starting Oct 31, 2025. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0229-2026 on Dec 24, 2025. Reason: Defective container: cracked/broken cartridges. Status: Ongoing.

Why it was recalled

Defective container: cracked/broken cartridges

Product description

Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Patterson Dental Supply, Inc., 1031 Mendota Heights Road, Saint Paul, MN55120, Manufactured by: Novocol Pharmaceutical of Canada, Inc., NDC 50227-1030-5.

Lot numbers, UPCs & expiration codes

Lot: D05362A, expires: 07-31-2027

Where it was sold

U.S.A. 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-0229-2026
Classification
Class II
Status
Ongoing
Recall initiated
Oct 31, 2025
FDA report date
Dec 24, 2025
Quantity
12,033 cartons
Recall type
Voluntary: Firm initiated
Recalling firm
Novocol Pharmaceutical of Canada, Inc.

Original FDA data

Every field from FDA enforcement report D-0229-2026, exactly as published.

Show all FDA fields
City
Cambridge
Status
Ongoing
Country
Canada
Event ID
98080
Address
25 Wolseley Crt
Code information
Lot: D05362A, expires: 07-31-2027
Report date
Dec 24, 2025
Product type
Drugs
Recall number
D-0229-2026
Classification
Class II
Recalling firm
Novocol Pharmaceutical of Canada, Inc.
Product quantity
12,033 cartons
Reason for recall
Defective container: cracked/broken cartridges
Voluntary / mandated
Voluntary: Firm initiated
Product description
Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Injection USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml each, Rx only, Manufactured for Patterson Dental Supply, Inc., 1031 Mendota Heights Road, Saint Paul, MN55120, Manufactured by: Novocol Pharmaceutical of Canada, Inc., NDC 50227-1030-5.
Distribution pattern
U.S.A. Nationwide
Recall initiation date
Oct 31, 2025
Initial firm notification
Letter
Center classification date
Dec 12, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0229-2026, published Dec 24, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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