Unclassified
Nystatin Cream
Failed Stability Specifications
Stability & shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency.
560 FDA drug recalls with this cause, newest first.
These recalls involve products whose stability data no longer supports the expiry date on the label, or that failed a stability test before that date. A medicine that loses potency early does not just stop working as well; it can also change chemically into something FDA never approved. The fix is usually a shorter shelf life for future lots.
- Total recalls
- 560
- Class I (high risk)
- 3
- Currently ongoing
- 138
- Most recent
- Sep 14, 2026
Most-cited firms for this cause
- Akorn, Inc.89
- American Pharmaceutical Ingredients LLC68
- Pharmedium Services, LLC66
- Teligent Pharma, Inc.39
- NingBo Huize Commodity Co.,Ltd.36
- Pharmakon Pharmaceuticals20
- Lloyd Inc. of Iowa20
- Pharma-Natural Inc.16
Class III · Low risk
Revcovi (elapegademase-lvlr)
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Fluphenazine HCl Elixir
Failed Stability Specifications
Class II · Moderate risk
Glucagon Emergency Kit for Low Blood Sugar
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Class III · Low risk
Pred Mild
Failed Stability Specifications
Class II · Moderate risk
Fungal Fusion ERADICATION Solution
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Class II · Moderate risk
TERPENICOL Antifungal Solution
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Class II · Moderate risk
vite20 Antifungal Cream
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Class II · Moderate risk
TERPENICOL Antifungal Cream
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Class II · Moderate risk
TRIPENICOL S Antifungal Solution
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Class II · Moderate risk
Blemish Spot Treatment
Failed Stability Specifications
Class II · Moderate risk
Maximum
Stability Data Does Not Support Expiry Date.
Class II · Moderate risk
Maximum
Stability Data Does Not Support Expiry Date.
Class II · Moderate risk
Five-Star
Stability Data Does Not Support Expiry Date.
Class II · Moderate risk
Phytonadione Injectable Emulsion
Failed Stability Specifications: Observed OOS results: eg results for colour index
Class II · Moderate risk
Lanthanum Carbonate chewable tablets
Failed stability specifications: Out of specification for hardness test
Class II · Moderate risk
Lanthanum Carbonate chewable tablets
Failed stability specifications: Out of specification for hardness test
Class II · Moderate risk
Succinylcholine Chloride Injection
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Class III · Low risk
Albuterol Sulfate
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Class II · Moderate risk
Gentamicin Injection
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
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