Class II · Moderate risk
Acetylcysteine Solution
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Is Acetylcysteine recalled?
Yes — there is an active recall. 4 ongoing FDA recalls mention Acetylcysteine (37 total). Check the affected lots below.
Most common reason: Sterility / contamination (30 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Acetylcysteine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Acetylcysteine recalls in 2026
2 initiated in 2026, 37 in total — newest first
Class II · Moderate risk
Acetylcysteine Solution
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Class II · Moderate risk
Acetylcysteine 10% Ophthalmic Solution
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
ACETYLCYSTEINE OPTH 5% Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
ACETYLCYSTEINE OPTH 10% Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Acetylcysteine 2% Opth Soln
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Acetylcysteine 10% Opth Soln
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Acetylcysteine Ophthalmic 10% Solution
Lack Of Processing Controls
Class II · Moderate risk
C-Acetylcysteine Ophth 10% Soln
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
Acetylcysteine 2% Otic Drop
Lack of Processing Controls
Class II · Moderate risk
Acetylcysteine 10% Ophthalmic Eye Drop 2 mL droptainer
Lack of sterility assurance.
Class II · Moderate risk
Acetylcysteine Ophthalmic Solution
Lack of sterility assurance.
Class II · Moderate risk
Acetylcysteine Injection 10 mg/5 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Acetylcysteine 10% Oph Solution
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Acetylcysteine for Injection 6 g/30 mL
CGMP Deviations
Class I · High risk
Cetylev (acetylcysteine)
Defective Container: Incomplete seal on blister packaging, leading to tablet swelling and enlarging due to effervescence process beginning as oxygen and moisture enter the blister packaging.
Class II · Moderate risk
Acetylcysteine 10% Ophth Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Acetylcysteine 10% Opthalmic Solution
Lack of assurance of sterility
Class II · Moderate risk
Acetylcysteine 10% Ophtalmic
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk
Acetylcysteine 10% Oph Solution
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II · Moderate risk
SO-Acetylcysteine 10% Sterile Ophthalmic Solution
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
Acetylcysteine 100 mg/ml Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Acetylcysteine 10% Opth Solution
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Acetylcysteine 10% opthalmic solution packaged in an opaque squeeze bottle eye dropper
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Class II · Moderate risk
Acetylcysteine 20%
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
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.