Class II · Moderate risk
Lysine for Injection
Lack of Assurance of Sterility
Is Lysine recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Lysine (15 total). Check the affected lots below.
Most common reason: Sterility / contamination (12 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Lysine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Lysine recalls on record
none so far in 2026; 15 on record, newest first
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
Goal-Glutamine 75mg/Ornithine 75mg/Arginine 150mg/Lysine…
Lack of assurance of sterility
Class II · Moderate risk
Lysine 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
S-Lysine HCL 100mg/Ml Mdv
Lack of Assurance of Sterility
Class II · Moderate risk
Lysine HCl
Lack of sterility assurance.
Class II · Moderate risk
Amino Blend Injection
Lack of sterility assurance.
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 I · High risk
Ibuprofen Lysine Injection
Presence of Particulate Matter
Class II · Moderate risk
Ultra Amino Blend
Lack of Assurance of Sterility
Class II · Moderate risk
Glutamine/ORNI/ARGIN/LYSINE/LIDO Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
L-Lysine Injection
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.