Class I · High risk
Morphine Sulfate 0.5 mg/mL
Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
Is Morphine recalled?
Yes — there is an active recall. 7 ongoing FDA recalls mention Morphine (189 total). Check the affected lots below.
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 on record
none so far in 2026; 189 on record, newest first
Class II · Moderate risk
Morphine Sulfate 0.5 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 20 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 11 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 1.5 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 10 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 50 mg/ml/Bupivacaine HCL 24 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 20 mg/ml/Bupivacaine HCL 11.3 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 0.6 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 9 mg/ml/Sufentanil Cit 180 mcg/ml/Bupivacaine HCL 33 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 0.5 mg/ml/Baclofen 1000 mcg/ml/
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 6 mg/ml/Bupivacaine HCL 32 mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
MORPHINE 10MG/ML in NS
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk
Morphine PF
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Morphine Sulfate
Stability data does not support expiry.
Class II · Moderate risk
Morphine Sulfate
Stability data does not support expiry.
Class II · Moderate risk
morphine Sulfate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
morphine Sulfate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
morphine Sulfate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
morphine Sulfate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
morphine Sulfate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
morphine Sulfate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
Morphine/0.9 % NaCl 1 mg/mL IV
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Morphine 40 mg/ml + Bupivacaine 16 mg/ml Solution
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Morphine 40 mg/ml + Bupivacaine 8 mg/ml Solution
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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