Quick answers
- What is Gastrografin?
- Gastrografin is a brand name of Diatrizoate meglumine and diatrizoate sodium, a prescription medicine. The FDA NDC Directory lists 1 Gastrografin product in 1 strength and form.
- Who makes Gastrografin?
- Bracco holds the FDA application for Gastrografin (NDA011245, approved January 17, 1958).
- Is there a generic or store brand of Gastrografin?
- Other products of Diatrizoate meglumine and diatrizoate sodium are listed with the FDA, but none in exactly the same strength and form as a Gastrografin product.
- Has Gastrografin been recalled?
- FDA enforcement reports list 2 recalls of Gastrografin products; the newest started April 13, 2022. A recall usually concerns specific lots, not every product.
What Gastrografin is
Each Gastrografin product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Diatrizoate meglumine and diatrizoate sodium · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| diatrizoate meglumine 660 mg/mL · diatrizoate sodium 100 mg/mL liquid (oral, rectal) | Gastrografin | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Diatrizoate meglumine and diatrizoate sodium →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA011245 | Bracco | January 17, 1958 | 1 |
Companies that list Gastrografin
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Gastrografin products.
- Bracco Diagnostics Inc1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 13, 2022 · Class II · Terminated · D-1086-2022
cGMP deviations: Temperature abuse
Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP), packaged in: Twenty-four 30 mL single dose bottles, Rx only, MFG: Bracco Diagnostics Inc., NDC 0270-0445-35 — Mckesson Medical-Surgical Inc. Corporate Office
-
June 21, 2013 · Class II · Terminated · D-885-2013
Presence of foreign substance: One lot of the product may contain black foreign particles
Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottle, Rx only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543 by Therapex, Division of E-Z-E — Bracco Diagnostics Inc
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.