Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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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 40 mg/ml + Fentanyl 2

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1603-2015
Class II · Moderate risk

Morphine 40 mg/ml Solution

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1599-2015
Class II · Moderate risk

Morphine 35 mg/ml Solution

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1597-2015
Class II · Moderate risk

Morphine 33 mg/ml Solution

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1596-2015
Class II · Moderate risk

Morphine 25 mg/ml Solution

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1592-2015
Class II · Moderate risk

Morphine 20 mg/ml Solution

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1588-2015
Class II · Moderate risk

Morphine 15 mg/ml Solution

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1587-2015
Class II · Moderate risk

Morphine 12.5 mg/ml Solution

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1586-2015
Class II · Moderate risk

Morphine 10 mg/ml Solution

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

Terminated Sterility / contamination The Compounding Pharmacy of America D-1585-2015
Class I · High risk

Morphine Sulfate

Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.

Terminated Wrong potency / content Pharmedium Services, LLC NDC 61553-401-44 D-0658-2016
Class I · High risk

Morphine Sulfate

Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride, USP injection which were subsequently recalled due to the presence of particulate matter (human hair).

Terminated Particulate / foreign matter Pharmedium Services, LLC NDC 61553-181-50 D-1824-2015
Class II · Moderate risk

Morphine/bupivacaine 5 mg/2 mg/mL injectable packaged in 30 mL or 60 mL syringes

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Terminated Sterility / contamination Martin Avenue Pharmacy, Inc. D-0105-2015
Class II · Moderate risk

Morphine sulfate

Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Terminated Sterility / contamination Martin Avenue Pharmacy, Inc. D-0104-2015