Pharmaceutical Associates Nystatin Oral Suspension Recall

Why it was recalled

Resuspension problems: Out of specification for appearance and resuspendability.

Product description

Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05

Lot numbers, UPCs & expiration codes

Lot: B5B8 Exp. 07/2019

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0865-2018
Classification: Class III
Status: Terminated
Recall initiated: May 29, 2018
FDA report date: Jun 13, 2018
Quantity: 275400 cups
Recall type: Voluntary: Firm initiated
Recalling firm: Pharmaceutical Associates Inc

Original FDA data

Every field from FDA enforcement report D-0865-2018, exactly as published.

Show all FDA fields

City: Greenville
State: SC
Status: Terminated
Country: United States
Event ID: 80190
Address: 201 Delaware St
Code information: Lot: B5B8 Exp. 07/2019
Postal code: 29605-5823
Report date: Jun 13, 2018
Product type: Drugs
Recall number: D-0865-2018
Classification: Class III
Recalling firm: Pharmaceutical Associates Inc
Product quantity: 275400 cups
Termination date: Jan 13, 2020
Reason for recall: Resuspension problems: Out of specification for appearance and resuspendability.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05
Distribution pattern: Nationwide
Recall initiation date: May 29, 2018
Initial firm notification: Letter
Center classification date: Jun 13, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0865-2018, published Jun 13, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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