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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Pharmaceutical Associates Inc: Nystatin Oral Suspension Recalled for Low Potency (Subpotent)

Agency Publication Date: January 24, 2020
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Summary

Pharmaceutical Associates Inc. has voluntarily recalled 6,288 bottles of Nystatin Oral Suspension (100,000 units per mL), a prescription medication used to treat fungal infections. Testing revealed that the medication was subpotent, meaning it did not meet the required strength specifications during a 12-month quality check. If the medication is not at full strength, it may not effectively treat the infection as intended. Consumers should contact their healthcare provider or pharmacist regarding their treatment and return any remaining product to the place of purchase for a refund.

Risk

The medication was found to be 'out of specification' for potency, which means the drug may not have enough active ingredient to effectively treat fungal infections. This could lead to a delay in recovery or the worsening of the patient's condition due to inadequate treatment.

What You Should Do

  1. Check your medicine cabinet for 16 fl oz (473 mL) bottles of Nystatin Oral Suspension, USP 100,000 units per mL in Cherry/Peppermint flavor.
  2. Verify the lot numbers and expiration dates on the bottle label. This recall specifically affects lot numbers BB70 and BB71, both with an expiration date of May 2020.
  3. Confirm the National Drug Code (NDC) 0121-0810-16 is printed on the label.
  4. Contact your healthcare provider or pharmacist immediately to discuss your treatment if you have been using the affected medication.
  5. Return any unused portion of the recalled medication to the pharmacy where you purchased it for a refund and contact Pharmaceutical Associates Inc. for further instructions.
  6. Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report adverse effects.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare consultation and refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor (16 fl oz / 473 mL)
Model:
NDC 0121-0810-16
Recall #: D-0824-2020
Lot Numbers:
BB70 (Exp. May 2020)
BB71 (Exp. May 2020)
Date Ranges: Expiration Date: May 2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84712
Status: Resolved
Manufacturer: Pharmaceutical Associates Inc
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 6288 16 oz bottles
Distributed To: Nationwide
Agency Last Updated: February 3, 2020

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.