Severe Congestion Nasal Spray — Class II drug recall D-0604-2022
Terminated recall by Perrigo Company PLC, reported 2022-03-02, distributed nationwide. CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient s
| Recall number | D-0604-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Perrigo Company PLC, Allegan, MI, United States |
| Recall initiated | 2021-10-26 |
| Classified | 2022-02-23 |
| Reported by FDA | 2022-03-02 |
| Terminated | 2023-09-29 |
| Distributed | Nationwide (US) |
| Quantity | 3,168 bottles |
| Reason classes | cgmp |
| NDC | 50594-0719-10 |
| Lot numbers | 1BK0827 |
| Expiration dates | 2022-12-31 |
Product
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Packaged by Perrigo Company for: Big Lots Stores, Inc., P.O. Box 28523, Columbus, OH 43228-0523. NDC: 50594-719-10
Reason for recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
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-0604-2022. 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.