The Recall Desk
ModerateFDA (Drugs)·D-0454-2023·Announced 2023-03-15

OTC Hemorrhoidal Ointment Recalled for Missing Lot and Expiration Date

Akron Pharma is recalling Dibucaine 1% Hemorrhoidal Ointment due to incorrect or missing lot and expiration date information on the label. This labeling error affects 4,416 tubes distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a FDA Class III recall involving a labeling defect. The issue is limited to incorrect or missing lot and expiration date information, with no reported illnesses, injuries, or adverse events. Per the rubric, FDA Class III recalls are typically scored 1–2; minor labeling errors fall under Score 2.

Plain-English summary

Akron Pharma, Inc. is recalling Dibucaine 1% Hemorrhoidal Ointment tubes due to a labeling defect. The affected product is Lot #2206016 with an expiration date of May 2024. The recall covers 4,416 tubes.

The labeling on the product contains incorrect or missing lot number and expiration date information. This labeling issue prevents proper product identification and traceability.

The affected product was distributed nationwide within the United States. Consumers who have this product should verify the lot number and expiration date on their package against the recalled lot information.

The recalled product

Product
DIBUCAINE (DIBUCAINE)
Brand
DIBUCAINE
Manufacturer
Akron Pharma, Inc.
Category
Drug — Topical OTC
Hazard
  • mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 2206016
  • Exp. date 05/2024

Distribution

Distributed nationwide across the United States.

Related recalls

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