Atropine Sulfate Injection Shortage: Latest Updates on Availability and Manufacturer Status
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The FDA reports a current shortage of Atropine Sulfate Injection due to manufacturing compliance requirements, with varying availability across major suppliers.
What this FDA drug-shortage notice tells you, and what most readers miss
This notice was issued by FDA on February 11, 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 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, Atropine Sulfate) 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
Atropine Sulfate Injection (Brand Name: ATROPINE SULFATE) is currently listed in a shortage status by the FDA. This medication is an injection used within the therapeutic categories of Anesthesia, Neurology, and Pediatrics.
Which Manufacturers Are Affected
Several manufacturers are involved in the production of Atropine Sulfate Injection, with varying levels of availability:
Accord Healthcare Inc.
- Status: Unavailable
- Details: The 1 mg/1 mL and .4 mg/1 mL presentations have a resupply date of "TBD." The .05 mg/1 mL and .1 mg/1 mL presentations have been discontinued.
- Contact: 866-941-7875, option 2
American Regent, Inc.
- Status: Available
- Details: Both the .4 mg/1 mL and 1 mg/1 mL presentations are currently available.
- Contact: 800-645-1706
Fresenius Kabi USA, LLC
- Status: Available
- Details: The .4 mg/1 mL presentation is available. The manufacturer suggests checking wholesalers for current inventory.
- Contact: 888-386-1300
Why There's a Shortage
According to the FDA, the reason for the current shortage is related to requirements for complying with good manufacturing practices.
What Patients Should Do
Patients who may require this medication for upcoming procedures or neurological care should be aware that while some manufacturers have discontinued certain presentations or are experiencing delays, supply remains available through other sources.
If you have concerns about your treatment, please:
- Consult with your healthcare provider or pharmacist regarding the availability of your medication.
- Contact the manufacturers listed above for specific information regarding their current supply levels.
Disclaimer: Patients should always consult their healthcare provider regarding their medical treatment and any potential concerns about medication availability.
Source
Information provided by the FDA Drug Shortage Database.
- Initial Posting Date: 01/01/2012
- Last Updated: 02/03/2026
Original source: FDA Official Notice ↗
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