Coated Phenylephrine HCl 5mg Tablet — Class II drug recall D-0546-2022
Terminated recall by ULTRAtab Laboratories, Inc., reported 2022-02-16. CGMP Deviations
| Recall number | D-0546-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ULTRAtab Laboratories, Inc., Highland, NY, United States |
| Recall initiated | 2022-01-26 |
| Classified | 2022-02-09 |
| Reported by FDA | 2022-02-16 |
| Terminated | 2025-01-07 |
| Quantity | 7,983,360 tablets |
| Reason classes | cgmp |
| NDC | 62959-0338-00 |
| Lot numbers | 19A070, 19B080, 19J043 |
Product
Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00
Reason for recall
CGMP Deviations
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-0546-2022. 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.