PredniSONE Tablets Recalled for Temperature Storage Deviation
Cardinal Healthcare is recalling PredniSONE 20 mg tablets nationwide (Batch 21P0659, NDC 59746-175-06) due to exposure to temperatures outside labeled storage conditions during manufacture, which could affect drug stability.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II manufacturing deviation with no reported illnesses or injuries. Temperature exposure outside storage conditions presents a theoretical risk to drug stability and potency, but no actual harm has been documented.
Plain-English summary
Cardinal Healthcare is recalling PredniSONE Tablets, USP, 20 mg (Batch 21P0659, NDC 59746-175-06) manufactured by Jubilant Cadista Pharmaceuticals Inc. The products were exposed to temperatures outside the labeled storage conditions during manufacturing, which violates Current Good Manufacturing Practice (CGMP) standards.
Temperature exposure outside specified storage ranges can affect the stability and potency of pharmaceutical products. While no illnesses or adverse events have been reported, the recall is being issued to prevent potential loss of medication efficacy for patients who depend on this drug.
The recall affects all units distributed nationwide under batch number 21P0659. Patients taking PredniSONE from this batch should contact their healthcare provider or pharmacist about obtaining a replacement supply from an unaffected batch. Healthcare providers and pharmacies should discontinue dispensing and quarantine all remaining inventory of the affected batch.
The recalled product
- Product
- PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801. NDC: 59746-175-06
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Corticosteroid
- Hazard
- temperature-exposure
- stability-risk
- potency-loss
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 (1)
- Batch 21P0659
Distribution
Distributed nationwide across the United States.
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