D-0266-2025 Class II Ongoing
FDA drug recall D-0266-2025 was initiated by Chattem Inc on Mar 4, 2025 and is designated Class II. Reason for recall: CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration. The recall status is ongoing. Affected quantity: 180,696 cartons.
Recall details
- Product Type
- Drugs
- Report Date
- Mar 19, 2025
- Initiation Date
- Mar 4, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 180,696 cartons
Product 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
Reason for recall
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Distribution pattern
Nationwide in the USA.
Code information
Lot# 252807, Exp: 5/31/2025; 252808, Exp: 6/30/2025; 372560, Exp: 11/30/2025; 489576, 493447, Exp: 4/30/2026.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0266-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026