Bacitracin Ophthalmic Ointment Shortage: Supply Issues Reported Due to Manufacturing Discontinuation

Source: FDA · United States

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Bacitracin Ophthalmic Ointment is currently unavailable from major suppliers due to manufacturing discontinuation, with shortages expected to persist for up to 20 months.

What this FDA drug-shortage notice tells you, and what most readers miss

This notice was issued by FDA on February 12, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — Drug Shortages — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA drug-shortage notice is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (drug-shortage, fda, medication, Bacitracin) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What's in Shortage

Bacitracin Ophthalmic Ointment (Brand Name: BACITRACIN) is currently listed in a shortage status. This medication is classified under the therapeutic categories of Anti-Infective and Ophthalmology and is administered as an ophthalmic ointment.

Which Manufacturers Are Affected

The following manufacturer is currently impacted:

  • Padagis US LLC
    • Status: Unavailable
    • Presentation: Bacitracin, Ophthalmic Ointment, 3.5 g (NDC 0574-4022-35)
    • Notes: The shortage for this product is estimated to last for approximately 20 months.
    • Contact Information: 866-634-9120

Why There's a Shortage

The current shortage is attributed to the discontinuation of the manufacture of the drug.

What Patients Should Do

Patients who rely on Bacitracin Ophthalmic Ointment should take the following steps:

  1. Consult Your Healthcare Provider: Speak with your doctor or ophthalmologist to discuss the shortage and determine the best course of action for your specific medical needs.
  2. Talk to Your Pharmacist: Your pharmacist can provide information on current local availability or help coordinate with your physician regarding alternatives.
  3. Contact the Manufacturer: For specific questions regarding supply timelines, you may contact Padagis US LLC at the number provided above.

Disclaimer: This article is for informational purposes only. Patients should always consult their healthcare provider for medical advice, diagnosis, or treatment options regarding medication changes.

Source

Information provided by the FDA Drug Shortage Database.

  • Initial Posting Date: 03/03/2025
  • Last Updated: 02/04/2026

Original source: FDA Official Notice ↗

All Drug Shortages →

Frequently Asked Questions

Common questions about this FDA drug-shortage notice.

What is this FDA drug-shortage notice about?
Bacitracin Ophthalmic Ointment is currently unavailable from major suppliers due to manufacturing discontinuation, with shortages expected to persist for up to 20 months.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more Drug Shortages updates?
Browse the full Drug Shortages feed on Areazine at areazine.com/drug-shortages/ for the latest updates from FDA and other agencies.