Novocol Pharmaceutical of Canada, Inc.

Complete recall history across all FDA and CPSC categories — 8 total recalls

Novocol Pharmaceutical of Canada, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (8)

FDA drug safety enforcement actions by Novocol Pharmaceutical of Canada, Inc.

Date Product Reason Class
Oct 31, 2025 Lidocaine HCI 2% and Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine Inj... Defective container: cracked/broken cartridges Class II
Oct 31, 2025 Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, U... Defective container: cracked/broken cartridges Class II
Oct 31, 2025 OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a cart... Defective container: cracked/broken cartridges Class II
Oct 31, 2025 2% Xylocaine DENTAL with Epinephrine 1:100,000 (Lidocaine HCI and Epinephrine... Defective container: cracked/broken cartridges Class II
Oct 31, 2025 3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI ... Defective container: cracked/broken cartridges Class II
Oct 31, 2025 darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Me... Defective container: cracked/broken cartridges Class II
Oct 31, 2025 Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [M... Defective container: cracked/broken cartridges Class II
Nov 20, 2020 Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), p... Labeling: Label mix-up Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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