Class I โ€” Serious Health Hazard

Serious health hazard โ€” there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Atropine Sulfate 0.4 mg/ml Injection Recalled by Pharmakon Pharmaceuticals Due to Undeclared Excipient

Date: April 21, 2014
Company: Pharmakon Pharmaceuticals
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Pharmakon Pharmaceuticals directly.

Affected Products

Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78.

Quantity: 5 Syringes

Why Was This Recalled?

Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.

Where Was This Sold?

This product was distributed to 4 states: IL, IN, MD, TX

Affected (4 states)Not affected

About Pharmakon Pharmaceuticals

Pharmakon Pharmaceuticals has 28 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report