Class II · Moderate risk
Glutathione INHALATION
Lack of Assurance of Sterility; objectionable conditions observed during a FDA inspection
Is Glutathione recalled?
Yes — there is an active recall. 8 ongoing FDA recalls mention Glutathione (79 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Glutathione. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Glutathione recalls on record
none so far in 2026; 79 on record, newest first
Class II · Moderate risk
Glutathione 200 mg/mL Injectable
Incorrect Product Formulation: An incorrect gas was used to remove the oxygen from the vial.
Class II · Moderate risk
Glutathione
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
GLUTATHIONE with preservative
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class I · High risk
Glutathione 100mg/mL Sterile Injection
Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing facility indicating that the products may not be sterile.
Class II · Moderate risk
Glutathione Injection USP
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Class II · Moderate risk
Relumins Advanced Glutathione
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims.
Class II · Moderate risk
Saluta (reduced glutathione)
Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.
Class II · Moderate risk
Tatiomax (reduced glutathione/hydrolyzed collagen)
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
Class II · Moderate risk
Glutathione Inhalation 200mg/5ml
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Glutathione 1.25%/Ascorbic 1.25%/DMSO 6.25%
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Glutathione 6%/ascorbic 1%/DMSO 6.25%
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
L-Glutathione inhalation
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Glutathione PF
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Class II · Moderate risk
L-Glutathione 200 mg/mL PF
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Class II · Moderate risk
RL Glutathione 100 mg/mL
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable.
Class II · Moderate risk
Glutathione 100 mg/mL Injectable
Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory.
Class II · Moderate risk
GLUTATHIONE/METHYL/LIDO 100/25/20 MG/ML INJ SOLN and…
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Glutathione/Lido 100mg/2%/Ml
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Glutathione 200 Mg/Ml
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Class II · Moderate risk
Glutathione 200 mg/ml Injection
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
L-glutathione 200mg/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.
Class II · Moderate risk
Glutathione 150mg/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.
Class II · Moderate risk
Glutathione "Reduced" 200mg/ml
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.
Class II · Moderate risk
Glutathione 200 mg/mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
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