Atropine Sulfate Injection Shortage: Current Status and Details

Source: FDA · United States

Areazine synthesizes this FDA drug-shortage notice directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Atropine Sulfate Injection is currently in shortage, affecting some manufacturers, with certain presentations available while others are discontinued.

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

This notice was issued by FDA on April 7, 2026 and geographically references United States. Its severity classification of "medium" 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 mitigations (alternative therapies, allocation timelines, manufacturer guidance) are available and which agency holds oversight.

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, Atropine Sulfate Injection) 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.

Atropine Sulfate Injection Shortage

As a professional health news writer for Areazine, we aim to provide accurate and empathetic information about drug shortages. Atropine Sulfate Injection is an important medication, and we understand the concern this may cause for those who rely on it.

What's in Shortage

The drug in shortage is Atropine Sulfate Injection, with the brand name ATROPINE SULFATE. It is available in injection dosage form and falls under the therapeutic categories of Anesthesia, Neurology, and Pediatric. The shortage status is current, with the initial posting date of January 1, 2012, and the last update on April 2, 2026.

Which Manufacturers Are Affected

Several manufacturers are involved in the supply of Atropine Sulfate Injection, with varying availability:

  • American Regent, Inc.: Available for presentations such as Atropine Sulfate, Injection, 0.4 mg/1 mL (NDC 0517-1004-25) and 1 mg/1 mL (NDC 0517-1001-25). Contact info: 800-645-1706.
  • Medefil, Inc.: Available for Atropine Sulfate, Injection, 1 mg/10 mL (0.1 mg/mL) Syringes (NDC 64253-400-91). Contact info: 630-682-4600.
  • Amphastar Pharmaceuticals, Inc.: Available for Atropine Sulfate, Injection, 0.1 mg/1 mL (NDC 76329-3340-1). Contact info: 800-423-4136.
  • Fresenius Kabi USA, LLC: Available for Atropine Sulfate, Injection, 0.4 mg/1 mL (NDC 63323-580-20), with a note to check wholesalers for inventory. Contact info: 888-386-1300.
  • Hospira, Inc., a Pfizer Company: Unavailable for Atropine Sulfate, Injection, 1 mg/10 mL (0.1 mg/mL) LifeShield® ABBOJECT® Glass Syringe (NDC 0409-4911-34) and 0.5 mg/5 mL (0.1 mg/mL) LifeShield® ABBOJECT® Glass Syringe (NDC 0409-4910-34) due to discontinuation of manufacturing; however, available for 0.25 mg/5 mL (0.05 mg/mL) Syringes (NDC 0409-9630-05). Contact info: 844-646-4398.

Why There's a Shortage

For some manufacturers, such as Hospira, Inc., the shortage is related to the discontinuation of the manufacture of the drug. No specific reason was provided for the other manufacturers.

What Patients Should Do

If you are affected by this shortage, we recommend speaking with your pharmacist to check on local availability. You may also contact the relevant manufacturers directly using the provided contact information. Remember, this article is for informational purposes only—patients should consult their healthcare provider for any personalized advice and not make changes to their medication without professional guidance.

Source

This information is sourced from the FDA Drug Shortages Database, with the shortage initially posted on January 1, 2012, and last updated on April 2, 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?
Atropine Sulfate Injection is currently in shortage, affecting some manufacturers, with certain presentations available while others are discontinued.
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 "medium" severity. Stay informed and follow agency guidance.
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.