Recall archive / FDA drug enforcement
Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, N... — FDA record D-0546-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 26, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00
- Reason
- CGMP Deviations
- Classification
- Class II
- Recalling firm
- ULTRAtab Laboratories, Inc.
- Quantity
- 7,983,360 tablets
- Agency-reported status
- Terminated
- Source record identifier
- D-0546-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Product Codes: M338 Bulk Lots: 19A070, 19B080, 19J043 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Bulk product was distributed to 3 distributors who may have distributed finished product.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Feb 16, 2022
- Recall initiation date
- Jan 26, 2022
- Center classification date
- Feb 9, 2022
- Termination date
- Jan 7, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.