Nighttime Sleep-Aid — Class III drug recall D-1472-2022
Terminated recall by LNK International, Inc., reported 2022-09-07, distributed nationwide. Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however
| Recall number | D-1472-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LNK International, Inc., Hauppauge, NY, United States |
| Recall initiated | 2022-08-04 |
| Classified | 2022-08-30 |
| Reported by FDA | 2022-09-07 |
| Terminated | 2023-03-03 |
| Distributed | Nationwide (US) |
| Quantity | 257,064 cartons |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00050428348734 |
| Expiration dates | 2023-08, 2023-09, 2023-11, 2023-12, 2024-03, 2024-05, 2024-06, 2024-10, 2024-11, 2025-01, 2025-04 |
Product
Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 34873 4.
Reason for recall
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
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-1472-2022. 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.