Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Arginine recalled?

Yes — there is an active recall. 12 ongoing FDA recalls mention Arginine (35 total). Check the affected lots below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Arginine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Arginine recalls on record

none so far in 2026; 35 on record, newest first
Class II · Moderate risk

L-Arginine 100 mg/ml Injectable

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-1561-2015
Class II · Moderate risk

L-Arginine 100 mg/ml Injectable

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-1441-2015
Class II · Moderate risk

ARGININE (R-Gene)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Beacon Hill Medical Pharmacy, P.C. D-938-2013
Class II · Moderate risk

L-ArGiNINE 200 mg/ml Injection

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Ongoing Sterility / contamination Lowlite Investments, Inc. D/B/A Olympia Pharmacy D-747-2013
Class II · Moderate risk

L-Arginine 100mg/ml 30ml

The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.

Terminated Other Main Street Family Pharmacy, LLC D-154-2014
Class II · Moderate risk

L-Arginine 500mg/Ml Injectable 2500 Ml 500 Ml

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1554-2012