Unisom — Class II drug recall D-0362-2025
Ongoing recall by Chattem Inc, reported 2025-04-23, distributed nationwide. CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphe
| Recall number | D-0362-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Chattem Inc, Chattanooga, TN, United States |
| Recall initiated | 2025-03-26 |
| Classified | 2025-04-11 |
| Reported by FDA | 2025-04-23 |
| Distributed | Nationwide (US) |
| Quantity | 129,240 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| UPC / GTIN / UDI-DI | 00041167006702 |
| Lot numbers | 22L603, 378999 |
| Expiration dates | 2025-10-20, 2027-02-20 |
Product
Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2
Reason for recall
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
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-0362-2025. 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.