Class III · Low risk
Levocarnitine Injection
Labeling: Missing Label
Is Levocarnitine recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Levocarnitine (13 total). Check the affected lots below.
Most common reason: Sterility / contamination (11 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Levocarnitine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Levocarnitine recalls in 2026
1 initiated in 2026, 13 in total — newest first
Class II · Moderate risk
Levocarnitine Oral Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Levocarnitine 500mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Levocarnitine 100mg/Ml Mdv Soln
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Levocarnitine 100mg/Ml Mdv Soln
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Levocarnitine Injection
Lack of Assurance of Sterility
Class II · Moderate risk
S-Levocarnitine 100mg/Ml Mdv Inj Soln
Lack of Assurance of Sterility
Class II · Moderate risk
Levocarnitine 170 mg/mL Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Levocarnitine 100mg/Ml
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Class II · Moderate risk
All Products Intended to be Sterile
Lack of Assurance of Sterility
Class II · Moderate risk
Lipotropic Gold
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
B-Complex/Adenosine Inj sol
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Levocarnitine Solution for injection
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
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