US Drug Recall Register
Class I · High risk Terminated Initiated Sep 27, 2011 (15 years ago)

Oxycodone HCl Oral Concentrate

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL

What was recalled

Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morphine Sulfate 20 mg/mL, Mfg: Lannett Co. Inc., Re-Packaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Cody Laboratories Inc., Cody, WY NDC 00527-1426-36

Recalling firm
Shamrock Medical Solutions Group LLC
NDC code
00527-1426-36
Origin
OH, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1447-2014

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

See all
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