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.

Morphine Sulfate 0.5 mg/mL Recalled by Pharmakon Pharmaceuticals Due to Super-Potent Drug: Out of specification for potency results...

Date: February 11, 2016
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

Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharmakon Pharmaceuticals, NDC 45183-0322-78.

Quantity: 75 Syringes

Why Was This Recalled?

Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.

Where Was This Sold?

This product was distributed to 2 states: IL, IN

Affected (2 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