US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jun 2, 2015 (11 years ago)

Morphine 50 mg/ml + Clonidine 100 mcg/ml Solution

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

What was recalled

Morphine 50 mg/ml + Clonidine 100 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Recalling firm
The Compounding Pharmacy of America
Origin
TN, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1609-2015

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Morphine recalls

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Class III · Low risk Ongoing

Morphine Sulfate Oral Solution 100 mg / 5 mL

Reason Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.

Winder Laboratories, LLC D-0223-2026
Class II · Moderate risk Ongoing

Morphine Sulfate 5 mg per 0.25 mL Oral Syringe

Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Safecor Health, LLC D-0254-2025