Unisom — Class II drug recall D-0266-2025
Ongoing recall by Chattem Inc, reported 2025-03-19, distributed nationwide. CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit def
| Recall number | D-0266-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Chattem Inc, Chattanooga, TN, United States |
| Recall initiated | 2025-03-04 |
| Classified | 2025-03-10 |
| Reported by FDA | 2025-03-19 |
| Distributed | Nationwide (US) |
| Quantity | 180,696 cartons |
| Reason classes | chemical contamination, cgmp, specification failure |
| Lot numbers | 252807, 252808, 372560, 489576, 493447 |
| Expiration dates | 2025-05-31, 2025-06-30, 2025-11-30, 2026-04-30 |
Product
Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pharmaceuticals, Inc., Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409, UPC # 0 41167 0014 0
Reason for recall
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
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-0266-2025. 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.