Teva PrednisoLONE Oral Solution Recall: Failed Stability Specifications
Teva Pharmaceuticals USA recalls PrednisoLONE Oral Solution 15mg/5mL with alcohol content 5% due to failed stability specifications. This medication is prescription-only and may be unsafe if not stored properly.
Lower-risk recall
Failed Stability Specifications
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What happened, in plain English
Teva Pharmaceuticals USA is recalling PrednisoLONE Oral Solution 15 mg/5mL bottles with 5% alcohol content because they failed stability tests. This could mean the medication becomes less effective or unsafe if stored improperly over time. Read more at govinfonow.com/recall/41781-teva-prednisolone-oral-solution-recall-failed-stability-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/41781-teva-prednisolone-oral-solution-recall-failed-stability-specifications · Updated October 8, 2026 · FDA enforcement record: FDA #D-0703-2017
Cite this page
“Teva PrednisoLONE Oral Solution Recall: Failed Stability Specifications.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41781-teva-prednisolone-oral-solution-recall-failed-stability-specifications. Based on FDA recall #D-0703-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0703-2017%22&limit=1).
Why it’s dangerous
The medication failed stability specifications, meaning it may lose effectiveness or become unsafe if stored improperly over time. This is a chemical stability issue, not a physical hazard like a fire or breakage.
Who’s affected
Prescription patients who have the specific 240mL bottle of PrednisoLONE Oral Solution with the listed lot numbers and expiration dates are affected. Patients using this medication for conditions like arthritis or autoimmune diseases are most at risk.
How to tell if you have this one
Check for the 240mL bottle labeled PrednisoLONE Oral Solution USP, 15 mg/5mL, with alcohol content 5% (v/v). Look for lot numbers 94358 (exp. 05/17), 94920A (exp. 07/17), or 97083A (exp. 12/17).
- Brand
Teva Pharmaceuticals USA- Category
Drug
What to do — step by step
Check Product Details
Identify the lot number and expiration date on the bottle to confirm if it's part of the recall.
Contact Your Doctor
Talk to your healthcare provider about alternative medications if you have the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have the recalled product?
Contact your doctor to discuss alternative medications. The recall does not require immediate disposal but needs proper storage to maintain effectiveness.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0703-2017 (March 28, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0703-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.