CLASS III Drug recall · Reported 17 May 2017 · FDA Enforcement Report
PrednisoLONE Oral Solution USP, 15 mg/, alcohol content: 5%(v/v) recalled
Teva Pharmaceuticals USA is recalling PrednisoLONE Oral Solution USP, 15 mg/, alcohol content: 5%(v/v), distributed nationwide in the US. The recall was initiated on 28 Mar 2017 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0703-2017
- FDA event ID
- 76871
- Recalling firm
- Teva Pharmaceuticals USA, North Wales, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 Mar 2017
- FDA classified
- 11 May 2017
- Reported
- 17 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 28 Mar 2017 | Recall initiated by company | |
| 11 May 2017 | Classified by FDA | +44 days |
| 17 May 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
PrednisoLONE Oral Solution USP, 15 mg/5mL, alcohol content: 5%(v/v) 240 mL bottle, Rx Only, Manufactured in Canada By: CONTRACT PHARMACEUTICALS LIMITED CANADA, Ontario, Canada, L5N 6L6, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-6118-87
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Stability Specifications
Which lots are affected?
Lot # 94358; Exp. 05/17 Lot # 94920A; Exp. 07/17 Lot # 97083A; Exp. 12/17
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
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| Drug | CLASS III | Pred Mild, prednisolone acetate ophthalmic suspension recalled by AbbViePred Mild | AbbVie | Potency & Assay | Nationwide |
| Drug | CLASS II | Prednisolone Oral Solution, USP, 15 mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | PrednisoLONE Oral Solution USP, 15 mg recalled by Akorn | Akorn | Packaging Defects | Nationwide |
| Drug | CLASS II | Prednisolone Acetate Ophthalmic Suspension recalledPrednisolone Acetate | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |