Recalling firm
Chattem Inc
Product type
Drug
Status
Ongoing
Report date
2025-03-19
Distribution
Nationwide in the USA.
Firm state
TN
Product quantity
180,696 cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
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
Code / lot info
Lot# 252807, Exp: 5/31/2025; 252808, Exp: 6/30/2025; 372560, Exp: 11/30/2025; 489576, 493447, Exp: 4/30/2026.
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.