Quick answers
- What is Human botulinum neurotoxin a/b immune globulin used for?
- The FDA-approved label (BabyBIG, California Department of Public Health, December 8, 2025) says: “BabyBIG ®, Botulism Immune Globulin Intravenous (Human), is indicated for the treatment of infant botulism caused by toxin type A or B in patients below one year of age. BabyBIG is an immune globulin intravenous (human) indicated for: Treatment of infant botulism caused by toxin types A or B in patients below one year of age.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Human botulinum neurotoxin a/b immune globulin have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Human botulinum neurotoxin a/b immune globulin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Human botulinum neurotoxin a/b immune globulin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Human botulinum neurotoxin a/b immune globulin?
- 1 company lists prescription products of Human botulinum neurotoxin a/b immune globulin in the FDA NDC Directory, including California Department of Public Health.
What Human botulinum neurotoxin a/b immune globulin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
BabyBIG ®, Botulism Immune Globulin Intravenous (Human), is indicated for the treatment of infant botulism caused by toxin type A or B in patients below one year of age. BabyBIG is an immune globulin intravenous (human) indicated for: Treatment of infant botulism caused by toxin types A or B in patients below one year of age.
— FDA label: BabyBIG, California Department of Public Health, effective December 8, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Babybig |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125034 | — | Date not on file | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 544491, 544495 |
|---|---|
| SPL set ID of the quoted label | 9ec59262-35c1-4d8e-8451-a7cfbacb0675 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA125034 |
| Active ingredients (FDA) | HUMAN BOTULINUM NEUROTOXIN A/B IMMUNE GLOBULIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — BabyBIG, California Department of Public Health, effective December 8, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- 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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →