PrediniSONE Tablets — Class III drug recall D-1035-2020
Terminated recall by Par Pharmaceutical Inc., reported 2020-03-25, distributed nationwide. Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Table
| Recall number | D-1035-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Par Pharmaceutical Inc., Chestnut Ridge, NY, United States |
| Recall initiated | 2020-03-04 |
| Classified | 2020-03-18 |
| Reported by FDA | 2020-03-25 |
| Terminated | 2021-04-09 |
| Distributed | Nationwide (US) |
| Quantity | 13,008 bottles |
| Reason classes | labeling |
| NDC | 00603-5335, 00603-5335-21, 00603-5335-32, 00603-5336, 00603-5336-21, 00603-5337, 00603-5337-15, 00603-5337-21, 00603-5337-31, 00603-5337-32, 00603-5338, 00603-5338-15, 00603-5338-21, 00603-5338-28, 00603-5338-31, 00603-5338-32, 00603-5339, 00603-5339-21, 00603-5339-28, 00603-5339-32 |
| Lot numbers | 12/21, 8672518 |
Product
PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31
Reason for recall
Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1035-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.