Class II · Moderate risk
L-Arginine HCl for Injection
Lack of Assurance of Sterility
Is Arginine recalled?
Yes — there is an active recall. 12 ongoing FDA recalls mention Arginine (35 total). Check the affected lots below.
Most common reason: Sterility / contamination (28 of these recalls)
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 for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
LX Bioboost Plus
Lack of Assurance of Sterility
Class II · Moderate risk
Amino Blend Glutamine 30 mg/mL Ornithine HCL 50 mg/mL Arginine…
Lack of assurance of sterility.
Class II · Moderate risk
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg
Super Potent and Failed Reconstitution Time
Class II · Moderate risk
GOAL (Glutamine/Ornithine/Arginine/Lysine 25mg/75mg/150mg/250mg/ml)
Lack of Assurance of Sterility
Class II · Moderate risk
GAC (Glutamine/Arginine/L-Carnitine)
Lack of Assurance of Sterility
Class II · Moderate risk
Goal-Glutamine 75mg/Ornithine 75mg/Arginine 150mg/Lysine…
Lack of assurance of sterility
Class II · Moderate risk
Arginine Hydrochloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Amino Acid Injection 50 g/1000 mL
Lack of Assurance of Sterility; bags have potential to leak
Class II · Moderate risk
Glutamine/Arginine/Carnitine in all strengths
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk
Amino Blend Injection
Lack of sterility assurance.
Class II · Moderate risk
Arginine Injections 100 mcg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Arginine 150 mg/ Lysine HCl 50 mg/ Glutamine 200 mg/g Topical Cream packaged in jars
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Glutamine
CGMP Deviations; FDA analysis deterrmined that the product does not contain glutamine and two unknown impurities were observed
Class I · High risk
grande X 5800 capsule
Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
Class II · Moderate risk
Ultra Amino Energy Cocktail
Lack of Assurance of Sterility
Class II · Moderate risk
Ultra Amino Blend
Lack of Assurance of Sterility
Class II · Moderate risk
Tri-Amino (Ornithine (L)
Lack of Assurance of Sterility
Class II · Moderate risk
L-Arginine HCL 100 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
GAC, L-Glutamine/L-Arginine/L-Carnitine 25 mg/100 mg/200 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Glutamine/Arginine/Carnitine 25 mg/100 mg/200 mg/mL Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Glutamine/ORNI/Arginine/LYS/CITRU+LIDO 75 mg/75 mg/150 mg/50 mg/100 mg/10 mg/mL Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Arginine/Citrulline/Ornit+Lido 100/100/100/10 mg/mL Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Arginine HCl 100 mg/mL Injectable
Lack of Assurance of Sterility
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