FDA Recalls Nystatin Oral Suspension for Subpotent Assay Levels
Pharmaceutical Associates Inc. is recalling Nystatin Oral Suspension because it failed potency testing at 12 months. Patients should stop using the product and consult their healthcare provider.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity level where the product may cause temporary or medically reversible health consequences. No specific injuries or illnesses are reported in the source text.
Plain-English summary
Pharmaceutical Associates Inc. is recalling Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottles. The recall involves 6,288 bottles from lots BB70 and BB71 with an expiration date of May 2020. The product was distributed nationwide in the United States.
The recall was initiated because the product was found to be subpotent, meaning it was out of specification for assay at the 12-month time point. This indicates that the medication may not contain the full amount of the active ingredient required to be effective.
Patients who have this product should stop using it and consult their healthcare provider for alternative treatment options. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- NYSTATIN (NYSTATIN)
- Brand
- NYSTATIN
- Manufacturer
- Pharmaceutical Associates Inc
- Category
- Drug — Antifungal
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lots: BB70
- BB71 Exp. May 2020
UPCs (1)
- 0301210810022
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · NYSTATIN
- ModerateNystatin Cream Recall Due to Low Potency Test Results
FDA (Drugs) · 2026-07-22
- ModerateNystatin Oral Suspension Recalled Due to CGMP Violation
FDA (Drugs) · 2021-08-18
- ModerateFDA Recalls Nystatin Oral Suspension Due to Subpotent Drug Levels
FDA (Drugs) · 2020-08-19
- ModerateNystatin Oral Suspension Recalled for Low Potency
FDA (Drugs) · 2020-04-01
- LowPharmaceutical Associates Recalls Nystatin Oral Suspension Due to Resuspension Issues
FDA (Drugs) · 2018-06-13
Same manufacturer · Pharmaceutical Associates Inc
See all →- ModeratePharmaceutical Associates Recalls Cyproheptadine HCl Syrup Due to Impurity
FDA (Drugs) · 2014-11-12
Same hazard · subpotent drug
See all →- ModerateAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- SevereAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02