The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0636-2026·Announced 2026-06-24

Med Pride bacitracin zinc ointment 500 units recalled over manufacturing deviations

Med Pride Bacitracin Zinc Ointment, 500 units per gram in 1 oz tubes, is being recalled because of CGMP deviations observed during an FDA inspection. 4,374 tubes affected.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: FDA Class II recall arising from inspection-observed manufacturing deviations with no product defect or consequence described, which fits the Moderate band.

Plain-English summary

Med Pride Bacitracin Zinc Ointment, 500 units, 1 oz (28.3 g) tubes, manufactured for Shield Line LLC of Bayonne, New Jersey and made in India, UPC 3 52410 30354 8, is being recalled. The action covers 4,374 tubes.

The stated reason is CGMP deviations and deficiencies observed during an FDA inspection. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.

Affected lots are 001 through 006, 010 through 014 and 016 through 020, within expiry. Distribution was USA nationwide.

Consumers who have an affected lot should stop using it and follow the instructions issued by the firm.

The recalled product

Product
Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30354 8.
Manufacturer
Dabur India Limited
Category
Drug — Topical antibiotic ointment
Hazard
Affected units
4,374

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 (17)

  • Lot# 001
  • 002
  • 003
  • 004
  • 005
  • 006
  • 010
  • 011
  • 012
  • 013
  • 014
  • 016
  • 017
  • 018
  • 019
  • 020
  • Within Expiry.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 recalled by Dabur India Limited under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

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