Cromolyn Sodium Concentrate (Gastrocrom) Shortage: Current FDA Status and Availability
Areazine synthesizes this FDA drug-shortage notice directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
The FDA reports an ongoing shortage of Cromolyn Sodium Concentrate, used for pulmonary and allergy conditions, though major manufacturers currently report availability.
What this FDA drug-shortage notice tells you, and what most readers miss
This notice was issued by FDA on April 6, 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 mitigations (alternative therapies, allocation timelines, manufacturer guidance) are available and which agency holds oversight.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are drug-shortage, fda, medication, Cromolyn Sodium.
What's in Shortage
Cromolyn Sodium Concentrate (generic) and its brand-name version, Gastrocrom, are currently listed on the FDA drug shortage database. This medication is categorized under Pulmonary/Allergy therapeutics and is supplied in a concentrate dosage form.
- Current Status: Current
- Initial Posting Date: 11/03/2023
- Last Updated: 02/04/2026
Which Manufacturers Are Affected
According to the latest FDA data, the following manufacturers are involved in the supply of this medication. While the shortage remains on the active list, both manufacturers currently report their specific presentations as available:
Mylan Specialty, a Viatris Company
- Status: Available
- Presentation: Gastrocrom, Concentrate, 20 mg/1 mL (NDC 0037-0678-96)
- Contact Info: (800) 796-9526
Micro Labs LTD
- Status: Available
- Presentation: Cromolyn Sodium, Concentrate, 100 mg/5 mL (NDC 42571-132-52)
- Contact Info: (908) 484-7410
Why There's a Shortage
At this time, the FDA has not provided a specific reason for the shortage of Cromolyn Sodium Concentrate.
What Patients Should Do
If you or a family member depends on this medication, the following steps are recommended to ensure continuity of care:
- Consult your pharmacist: Local supply may vary. Your pharmacist can check regional stock and provide updates on when new shipments are expected.
- Talk to your healthcare provider: Discuss your treatment options and ask about alternatives if you have difficulty obtaining your regular prescription.
- Contact the manufacturer: For specific questions regarding supply and distribution, you may reach out to the manufacturers directly using the phone numbers provided above.
Disclaimer: This article is for informational purposes only. Patients should always consult with their healthcare provider or a qualified medical professional regarding their treatment and any potential changes to their medication regimen.
Source
Information sourced from the FDA Drug Shortage Database.
Original source: FDA Official Notice ↗
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