Class I · High risk
Morphine Sulfate Injection
Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Is Morphine recalled?
Yes — there is an active recall. 7 ongoing FDA recalls mention Morphine (189 total). Check the affected lots below.
Most common reason: Sterility / contamination (135 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Morphine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Morphine recalls in 2026
1 initiated in 2026, 189 in total — newest first
Class III · Low risk
Morphine Sulfate Oral Solution 100 mg / 5 mL
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Class II · Moderate risk
Morphine Sulfate 5 mg per 0.25 mL Oral Syringe
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II · Moderate risk
Morphine Sulfate Extended-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Morphine Sulfate Extended-Release Tablets 30 mg
Failed Impurities/Degradation Specification
Class II · Moderate risk
Morphine Sulfate Extended-Release Tablets 15 mg
Failed Impurities/Degradation Specification
Class II · Moderate risk
Infumorph (Preservative-free Morphine Sulfate Sterile Solution)
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Class III · Low risk
Opium Tincture
Subpotent Drug
Class II · Moderate risk
morphine in 0.9% Sodium Chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
morphine in 0.9% sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
morphine in 0.9% sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
morphine in 0.9% sodium chloride
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
MORPHINE Sulfate
Lack of sterility assurance
Class II · Moderate risk
Morphine Sulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate Injection
Lack of Assurance of Sterility
Class I · High risk
Morphine Sulfate extended-Release Tablets
Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
Class I · High risk
Morphine Sulfate extended-Release Tablets
Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
Class I · High risk
Morphine Sulfate PF 25 mg/25mL
Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
Class III · Low risk
Morphine Sulfate Oral Solution 100 mg per 5 mL
Labeling: Missing Label
Class II · Moderate risk
Morphine Sulfate
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate in 5% Dextrose Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate Injection
Defective container: Cracked vials leading to lack of sterility assurance
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