CLASS III Drug recall · Reported 25 Mar 2020 · FDA Enforcement Report
PrediniSONE Tablets, USP 5 mg recalled by Par Pharmaceutical
Par Pharmaceutical is recalling PrediniSONE Tablets, USP 5 mg, distributed nationwide in the US. The recall was initiated on 4 Mar 2020 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-1035-2020
- FDA event ID
- 85136
- Recalling firm
- Par Pharmaceutical, Chestnut Ridge, NY
- Brand
- Prednisone
- Manufacturer
- Par Health USA, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Mar 2020
- FDA classified
- 18 Mar 2020
- Reported
- 25 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 4 Mar 2020 | Recall initiated by company | |
| 18 Mar 2020 | Classified by FDA | +14 days |
| 25 Mar 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
Product as listed by the FDA
PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
Which lots are affected?
Lot #: 8672518, Exp 12/21
Where was it sold?
U.S.A. 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.
More recalls from Par Pharmaceutical
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | BusPIRone Hydrochloride Tablets, USP 7.5 mg recalled | Par Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS II | Glycopyrrolate Tablets, USP 1 mg recalled by Par Pharmaceutical | Par Pharmaceutical | Potency & Assay | NY |
| Drug | CLASS III | Frovatriptan Succinate Tablets, 2.5mg recalled by Par Pharmaceutical | Par Pharmaceutical | Labeling Errors | Nationwide |
| Drug | CLASS I | Mycophenolate Mofetil for Injection, USP 500 mg Dose Vials recalledMycophenolate Mofetil | Par Pharmaceutical | Particulate Matter | Nationwide |
| Drug | CLASS III | Pramipexole dihydrochloride extended release tablets, 0.75 mg recalled | Par Pharmaceutical | Potency & Assay | Nationwide |
Other Prednisone recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | PredniSONE Tablets, USP, 20 mg recalled by Cardinal Healthcare | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Prednisone Tablets USP, 20 mg recalled by Strides PharmaPrednisone | Strides Pharma | Other | Nationwide |
| Drug | CLASS II | Prednisone Tablets, USP 2.5 mg recalled by Lannett Company | Lannett | Other | Nationwide |
| Drug | CLASS II | PredniSONE Tablets USP, 1 mg recalled by West-Ward PharmaceuticalPrednisone | West-Ward Pharmaceutical | Other | Nationwide |
| Drug | CLASS III | Prednisone 20 mg, Tablet recalled by Northwind Pharmaceuticals | Northwind Pharmaceuticals | Packaging Defects | Nationwide |