Quick answers
- What is Cytotec?
- Cytotec is a brand name of Misoprostol, a prescription medicine. The FDA NDC Directory lists 2 Cytotec products in 2 strengths and forms.
- Who makes Cytotec?
- Pfizer holds the FDA application for Cytotec (NDA019268, approved December 27, 1988).
- Is there a generic or store brand of Cytotec?
- Yes. The FDA NDC Directory lists 23 other products with the same active ingredients, strength and form as a Cytotec product, 23 of them generic. Ask your pharmacist whether one is right for you.
- Has Cytotec been recalled?
- FDA enforcement reports list 1 recall of Cytotec products; the newest started September 9, 2016. A recall usually concerns specific lots, not every product.
What Cytotec is
Each Cytotec 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.
Misoprostol · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| misoprostol 100 ug tablet (oral) | Cytotec | 8 products, 7 companies | DailyMed |
| misoprostol 200 ug tablet (oral) | Cytotec | 15 products, 13 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Misoprostol →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA019268 | Pfizer | December 27, 1988 | 2 |
Companies that list Cytotec
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Cytotec products.
- Pfizer Laboratories Div Pfizer Inc2 products
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.
-
September 9, 2016 · Class III · Terminated · D-0424-2017
Failed Impurities/Degradations Specifications; Out of specification results for two known degradation products and total impurities at 18 months
Cytotec (misoprostol) Tablets, 200 mcg, 100 Tablets blister pack (10X10), For in-institution use only, Rx only, Distributed by G.D. Searle, Division of Pfizer, Inc., NY, NY --- NDC 0025-1461-34 — Pfizer 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.