Class II · Moderate risk
Cromolyn Sodium Oral Solution
CGMP deviation: product released prior to supplier approval.
Is Cromolyn recalled?
Yes — there is an active recall. 2 ongoing FDA recalls mention Cromolyn (6 total). Check the affected lots below.
Most common reason: cGMP deviation (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Cromolyn. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Cromolyn recalls on record
none so far in 2026; 6 on record, newest first
Class II · Moderate risk
Cromolyn Sodium Ophthalmic Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Cromolyn Sodium Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
C-Cromolyn Sod 20 Mg/2 Ml Inhalation Solution
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
NasalCrom (cromolyn sodium)
CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manufacture this product lot.
Class II · Moderate risk
Cromolyn sodium 1% inhalant solution packaged in a 3 mL or 7 mL vial
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.