FDA recalls 3 American Regent epinephrine lots after cracked vial complaints

The US Food and Drug Administration (FDA) published a 3 September 2026 nationwide recall of three lots of American Regent Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) after complaints of leaking and cracked multi-dose vials.

The highest-stakes readers are COOs, pharmacy directors and medical directors. The immediate UAE issue is inventory control, not panic. The FDA notice says the affected lots were distributed nationwide in the United States, so Dubai clinics should first verify whether any US-sourced emergency medicines entered their procurement chain, then document the check under Dubai Health Authority (DHA) expectations. Abu Dhabi and Al Ain operators should apply the same control through Department of Health Abu Dhabi (DOH) governance, while Sharjah, Ajman, Umm Al Quwain, Ras Al Khaimah and Fujairah providers should watch Ministry of Health and Prevention (MOHAP) and Emirates Drug Establishment (EDE) channels for any UAE action.

What the FDA recall covers

The recalled product is a 30 mL multi-dose vial of epinephrine at 1 mg/mL, used by or under the direction of a physician for anaphylaxis and for raising mean arterial blood pressure in adults with septic shock. It is a facility-use injectable, not the common patient-carried epinephrine auto-injector format.

“Customer complaints were received for leaking and cracked vials.”
American Regent company announcement posted by the FDA, 3 September 2026

The FDA recall notice names NDC 0517-3030-01 and three lots: 25128L1C0, expiring August 2026; 25280L1C0, expiring October 2026; and 26108L1C0, expiring July 2027. US distribution ran across three windows: 4 September 2025 to 18 December 2025, 16 December 2025 to 17 April 2026, and 15 June 2026 to 31 July 2026.

American Regent said its investigation found particulate matter identified as Nylon, Cellulosic, Acrylic, Polyethylene and Glass. The company said it had received no adverse event reports linked to the recall as of the notice date.

Why UAE operators should care

UAE providers should treat this as a supply-chain traceability test. Epinephrine is held in emergency rooms, crash carts, procedure rooms, dental sedation areas and some ambulatory settings. A cracked vial can break sterility assurance. Particulate matter in an injectable product can create serious clinical risk when the drug is given intravenously.

For Dubai operators, the practical task is to match the vial label, NDC where present, lot number and expiry date against pharmacy purchasing records. DHA circulars commonly address private health facilities and healthcare practitioners when MOHAP recall notices require adherence. DHA has also directed adverse drug reaction reporting to MOHAP within 15 working days in a prior public circular on medicine and medical product safety reporting.

For Abu Dhabi providers, the DOH Lists and Tools page includes a search tool for approved drugs available in the Abu Dhabi market. That makes the first question simple: is the exact American Regent vial in the approved local medicine record or in your internal import records? If it is absent, the second question is whether any physician-supplied or special-order stock bypassed the usual formulary process.

• Quarantine any vial matching 25128L1C0, 25280L1C0 or 26108L1C0.
• Record the cart, cabinet or clinic room where the vial was found.
• Check whether an adverse event, near miss or product-quality complaint needs reporting to DHA, DOH, MOHAP or EDE.
• Replace the stock before the next emergency readiness check.

Costs, cover and patient risk

The P&L exposure is small per vial and large in operational consequence. There is no single public UAE price for this exact American Regent product. CFOs should check the facility drug master, distributor invoice, payer tariff file and claim rules before assigning an AED value. For insured encounters, confirm replacement billing treatment with contracted payers, including Daman and Thiqa in Abu Dhabi networks and Sukoon where the provider has a Dubai or UAE contract.

Patients using prescribed emergency epinephrine should check product format before reacting to the headline. The recalled item is a 30 mL vial. A patient carrying an auto-injector should compare the brand, strength, lot and expiry against the official recall notice or ask a licensed pharmacist.

What comes next is local surveillance. UAE pharmacy leaders should monitor EDE, MOHAP, DHA and DOH notices over the next 30 days, because US recalls can trigger local checks when the same manufacturer, batch or distributor route touches the UAE. Clinics seeking replacement suppliers or licensed pharmacy partners can use the UAE Open Healthcare Directory, which lists more than 12,386 licensed providers, including pharmacy providers.