Cromolyn Sodium Concentrate (Gastrocrom) Shortage: Current FDA Status and Availability
According to the U.S. Census Bureau's American Community Survey (ACS) 5-year estimates, the CDC PLACES population-level health analysis, and the CMS Hospital Compare quality data, Areazine publishes editorial articles drawing on more than 19,000 U.S. city profiles. 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 February 11, 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 a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it 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 notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA drug-shortage notice 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) 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.
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 ↗
Related Drug Shortages
All Drug Shortages →Frequently Asked Questions
Common questions about this FDA drug-shortage notice.
What is this FDA drug-shortage notice about? ▾
Which agency issued this alert? ▾
How severe is this alert? ▾
What area is affected? ▾
Where can I find more Drug Shortages updates? ▾
Primary source data
EPA Outdoor Air Quality Data
Federal monitoring network — every measurement we report
AirNow (EPA / NOAA)
Real-time AQI for every monitored U.S. location
National Weather Service
Active watches, warnings, and advisories — NOAA
CDC Air Quality & Health
Health-impact reference behind every AQI category