FDA recalls 3 epinephrine lots after cracked vial reports: UAE clinics should check stock

American Regent, Inc. has recalled three lots of Epinephrine Injection, USP 30 mg/30 mL (1 mg/mL) in the US after complaints about leaking and cracked multidose vials, according to a US Food and Drug Administration (FDA) notice published on 3 September 2026.

For UAE operators, the immediate issue is inventory control. Dubai clinics, day surgery centres, emergency rooms and pharmacies should treat the FDA notice as a stock-check trigger, then wait for any local action through the Ministry of Health and Prevention (MOHAP), the Dubai Health Authority (DHA) or the Department of Health Abu Dhabi (DOH). The recall is US nationwide. The FDA notice does not state that the affected lots were distributed in the UAE.

What was recalled

The recalled product is American Regent Epinephrine Injection, USP, supplied as a 30 mg/30 mL multidose vial. The FDA-posted company notice says customer complaints reported leaking and cracked vials. American Regent's investigation also found particulate matter identified as Nylon, Cellulosic, Acrylic, Polyethylene and Glass.

• Lot 25128L1C0, expiry August 2026, distributed in the US from 4 September 2025 to 18 December 2025.
• Lot 25280L1C0, expiry October 2026, distributed in the US from 16 December 2025 to 17 April 2026.
• Lot 26108L1C0, expiry July 2027, distributed in the US from 15 June 2026 to 31 July 2026.

The product is used under physician direction by intravenous, intramuscular or subcutaneous routes. Indications include anaphylaxis and raising mean arterial blood pressure in adults with hypotension associated with septic shock.

Healthcare facilities should "stop using and return" affected product, according to American Regent's notice posted by the FDA on 3 September 2026.

The notice says American Regent had received no adverse event reports linked to the recall as of 3 September 2026. It also says particulate matter in an injectable product can cause serious harm, including blocked blood vessels, pulmonary embolism, organ damage or death. Cracked vials can compromise sterility and create contamination risk.

Why Dubai operators should care first

Dubai providers are exposed if procurement teams bought US-labelled stock through a distributor, if emergency trolleys carry multidose epinephrine vials, or if older crash-cart stock has not been rotated. DHA's pharmacy guidelines section 14.4 recommends that pharmacies maintain a recall system managed by the pharmacist in charge.

The practical check is narrow. Pharmacy managers should compare the vial label, carton, purchase invoice and supplier batch certificate against the three FDA lot numbers. Any matching product should be quarantined, photographed, logged in the controlled stock register where applicable, and escalated to the supplier and facility medical director. Patient-facing communication should wait for a confirmed match or a UAE regulator circular.

Abu Dhabi providers should apply the same check under DOH governance, including Al Ain sites. DOH has a Policy for Quarantine and Recall of Medical Products, which covers medical products that fail to comply with UAE pharmacy law. Northern emirates providers should monitor MOHAP circulars because MOHAP is the federal route for many medicine recall notices outside Dubai and Abu Dhabi.

Cost, claims and patient handling

CFOs should separate three costs: replacement stock, wastage and clinical disruption. The FDA notice does not give a UAE price. UAE teams should pull the AED cost from their own supplier invoice, then compare it with the approved formulary price, payer tariff and distributor credit note.

Insurers including Daman, Thiqa and Sukoon matter only where the patient has a covered pharmacy or emergency benefit. Claims teams should check whether replacement medication is billed to the insurer, supplied by the facility, or credited through the distributor. Medical directors should confirm that alternative epinephrine presentations remain available in emergency areas before any affected stock is removed.

Patients should not be told to discard medicine without checking the exact product and lot. This recall concerns American Regent multidose vials, not every epinephrine product. Patients carrying auto-injectors should check the brand, strength, lot number and expiry date, then ask a licensed pharmacist or physician if there is any uncertainty.

The next UAE signal to watch is a MOHAP circular or a regulator notice relayed by DHA or DOH. Until then, operators should run a documented batch check within 24 hours, record a nil finding if no stock matches, and brief emergency, pharmacy and insurance billing teams. Patients looking for a licensed pharmacy provider can use the UAE Open Healthcare Directory to find DHA, DOH and MOHAP-registered pharmacy providers across the Emirates.