Cromolyn Sodium Concentrate Shortage: FDA Update
Cromolyn Sodium Concentrate is currently in shortage according to the FDA, affecting its availability for pulmonary and allergy treatments, though one manufacturer reports it as available.
What this drug shortages alert tells you, and what most readers miss
This notice was issued by FDA on April 8, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — Drug Shortages — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim an alert like this, check whether they are personally affected, and move on. The more useful lens is to read the alert as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar alerts have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized drug shortages advisory is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (drug-shortage, fda, medication, Cromolyn Sodium Concentrate) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
Cromolyn Sodium Concentrate Shortage
What's in Shortage
The drug in shortage is Cromolyn Sodium Concentrate, with the brand name CROMOLYN SODIUM. It is available in concentrate dosage form and is currently in shortage status. This medication falls under the therapeutic category of Pulmonary/Allergy. The shortage was first posted on 11/03/2023 and last updated on 04/01/2026.
Which Manufacturers Are Affected
Micro Labs LTD is the manufacturer affected, and it reports the drug as available. Their presentation is Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 42571-132-52). Contact information for Micro Labs LTD is (908) 484-7410.
Why There's a Shortage
No specific reason for the shortage was provided in the source data.
What Patients Should Do
Patients who rely on this medication should speak with their pharmacist to check current availability. They can also contact the manufacturer directly for more information. Remember, patients should consult their healthcare provider for any guidance on their treatment; this article does not provide medical advice.
Source
This information is from the FDA Drug Shortage Database.
Source: FDA Official Notice