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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

PAI Holdings, LLC. dba Pharmaceutical Associates Inc: Nystatin Oral Suspension Recalled for Subpotency

Agency Publication Date: March 25, 2020
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Summary

Pharmaceutical Associates Inc. is recalling 7,416 bottles of Nystatin Oral Suspension, USP (100,000 units per mL), an antifungal medication used to treat yeast infections in the mouth. The recall was initiated because testing showed the drug is subpotent, meaning it contains less of the active ingredient than required. This cherry/peppermint flavored medication was distributed nationwide in 16 fl oz (473 mL) bottles. Consumers should check their medicine cabinets for the specific lot number BE85 to determine if their product is affected.

Risk

Because the medication is subpotent, it may not effectively treat the fungal infection as intended. This could lead to a prolonged infection or the worsening of symptoms because the patient is not receiving the full prescribed dose of the antifungal agent.

What You Should Do

  1. Check your prescription bottle of Nystatin Oral Suspension, USP (100,000 units per mL), Cherry/Peppermint Flavor, 16 fl oz (473 mL).
  2. Look for Lot Number BE85 with an expiration date of 11/2020 on the bottle label. This lot is identified by NDC 0121-0810-16.
  3. If your bottle matches this lot number, contact your healthcare provider or pharmacist immediately for guidance on continuing your treatment.
  4. Return any unused portion of the affected medication to the pharmacy where it was purchased for a refund.
  5. Contact Pharmaceutical Associates Inc. at the address 1700 Perimeter Rd, Greenville, SC 29605 for further instructions regarding this recall.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy 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 bottle)
Model:
NDC 0121-0810-16
Recall #: D-1060-2020
Lot Numbers:
BE85 (Exp. 11/2020)
Date Ranges: Expiration 11/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85302
Status: Resolved
Manufacturer: PAI Holdings, LLC. dba Pharmaceutical Associates Inc
Sold By: pharmacies
Manufactured In: United States
Units Affected: 7416 bottles
Distributed To: Nationwide

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.