PlainRecalls

Mohnark Pharmaceuticals Recalls Lidocaine Topical Anesthetic Cream Due to Failure to Meet Child-Resistant Packaging Requirement; Risk of Poisoning (Recall Alert)

Reported: June 30, 2022 Initiated: June 30, 2022 #22754 About 9,000 units

Mohnark Pharmaceuticals Inc., of Davie, Fla. issued this CPSC recall on June 30, 2022. Classified as Moderate severity. Approximately About 9,000 units are affected. The recall was issued because: The product contains lidocaine which must be in child resistant packaging as required by the Poison Prevention Packagin…. This recall notice is sourced from official CPSC enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This CPSC action (record #22754) was formally reported on June 30, 2022. It is classified under Moderate severity, with a current status of Active. Mohnark Pharmaceuticals Inc., of Davie, Fla. is listed as the recalling firm. Federal records indicate About 9,000 units are affected.

The documented reason for this recall is: The product contains lidocaine which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging is not child resistant, posing a risk of poisoning to young children if … Distribution information was not included in the agency filing, so consumers should assume broad potential exposure until the firm publishes point-of-sale details. The remedy documented by the agency is: Consumers should immediately stop using the recalled cream and store it in a location out of sight and reach of children. Contact Mohnark Pharmaceuticals for instructions on how to dispose of the pro… — consumers holding this product should act on that instruction rather than relying on general guidance.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 1 were also issued by CPSC. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Moderate

Units Affected

About 9,000

Related Recalls

6

1 from same agency

Product Description

The recall involves Mohnark Pharmaceuticals Lidocaine 4% Topical Anesthetic Cream. The product was sold in a white tube with a flip-top closure. Mohnark Pharmaceuticals is printed under the blue and green logo on the right side of the product tube. The lot code is located at the bottom of the product tube. The affected lot codes are 01202201, 210201, 210301, 210503, 210505, 210601, 211002 and 210401. The UPC 860002324906 is located on bottom side panel of the packaging.

Reason for Recall

The product contains lidocaine which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging is not child resistant, posing a risk of poisoning to young children if they ingest the anesthetic cream.

Remedy

Consumers should immediately stop using the recalled cream and store it in a location out of sight and reach of children. Contact Mohnark Pharmaceuticals for instructions on how to dispose of the product to receive a full refund. Mohnark Pharmaceuticals is contacting all known purchasers directly.

Recall Profile

Structured summary of the CPSC recall record
Attribute Value
Agency U.S. Consumer Product Safety Commission
Severity class Moderate
Status Active
Recall number 22754
Date reported June 30, 2022
Date initiated June 30, 2022
Recalling firm Mohnark Pharmaceuticals Inc., of Davie, Fla.
Units affected About 9,000
Distribution Not disclosed

Profile values are sourced directly from the official CPSC enforcement record. Source: U.S. Consumer Product Safety Commission.

Scale of Impact

About 9,000 units affected — limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units)
Large-scale (100K – 1M units)
Massive (≥1M units)

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Consumer Product Safety Commission filings.

Frequently Asked Questions

What product was recalled?
The recall involves Mohnark Pharmaceuticals Lidocaine 4% Topical Anesthetic Cream. The product was sold in a white tube with a flip-top closure. Mohnark Pharmaceuticals is printed under the blue and green logo on the right side of the product tube. The lot code is located at the bottom of the product tube. The affected lot codes are 01202201, 210201, 210301, 210503, 210505, 210601, 211002 and 210401. The UPC 860002324906 is located on bottom side panel of the packaging.. Recalled by Mohnark Pharmaceuticals Inc., of Davie, Fla.. Units affected: About 9,000.
Why was this product recalled?
The product contains lidocaine which must be in child resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The packaging is not child resistant, posing a risk of poisoning to young children if they ingest the anesthetic cream.
What should consumers do?
Consumers should immediately stop using the recalled cream and store it in a location out of sight and reach of children. Contact Mohnark Pharmaceuticals for instructions on how to dispose of the product to receive a full refund. Mohnark Pharmaceuticals is contacting all known purchasers directly.
Which agency issued this recall?
This recall was issued by the CPSC on June 30, 2022. Severity: Moderate. Recall number: 22754.
How do I check if my product is affected by a recall?
Check the product description and recall number (22754) against your product. Visit the official CPSC website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
How do I report an injury from a recalled product?
Report injuries to the issuing agency: CPSC at SaferProducts.gov, NHTSA at nhtsa.gov/report-a-safety-problem, or FDA via MedWatch. Document the product (photos, model/serial numbers, purchase receipts) and seek medical attention. Injury reports help agencies track hazard patterns and may strengthen enforcement actions.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

Compare this recall with Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, … →

Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).