Recall D-0266-2025
Description: 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
Recall D-0266-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0266-2025 |
| Event ID | 96391 |
| Distribution | Nationwide in the USA. |
| Quantity | 180,696 cartons |
| Recall Reason | CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration. |
| Drug Classification | Class II |
| Drug Code Info | 20250319 |
| Recall Initiation Date | 20250304 |
| Report Date | 20250319 |
| Classification Date | 20250310 |
| Address | 1715 W 38th St Chattanooga, TN 37409-1248 United States |
| Recalling Firm | Chattem Inc |
| Similar To |