Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

National Drug Code

Is NDC 0121-0868-02 recalled?

Nystatin · 60 mL in 1 BOTTLE, DROPPER (0121-0868-02)

Yes — this exact package was recalled

1 FDA recall names the code 0121-0868-02 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

Active ingredient
Nystatin
Strength
NYSTATIN 100000 [USP'U]/mL
Form
Suspension · Oral
Labeler
PAI Holdings, LLC dba PAI Pharma
Type
Human Prescription Drug
Product code
0121-0868

Recalls naming this package

Class II ยท Moderate risk

Nystatin Oral Suspension

Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.

Terminated cGMP deviation PAI Holdings, LLC. dba Pharmaceutical Associates Inc NDC 0121-0868-16 D-0721-2021

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler