Class II Recall Issued for Unisom Sleep Aid Due to Nitrosamine Impurities

Chattem Inc. has voluntarily initiated a Class II recall of its Unisom SleepMinis (diphenhydramine HCl) 25 mg mini-capsules, distributed in 60-count bottles nationwide. The recall, listed under US Food and Drug Administration (FDA) recall number D-0362-2025, affects 2 specific lots—LOT 22L603 (expiration October 2025) and LOT 378999 (expiration February 2027)—with a total of 129 240 bottles subject to removal from the market. While no press release has been issued to date, the recall remains ongoing.

The recall was triggered by current good manufacturing practice (CGMP) deviations related to the detection of nitrosamine drug substance-related impurities (NDSRI), specifically N-nitroso-desmethyl-diphenhydramine (n-dph), found to exceed the FDA’s recommended intake limits. Nitrosamines are classified as probable human carcinogens, and their presence in pharmaceutical products has been a growing concern for regulatory agencies worldwide. The FDA classified this as a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

Unisom SleepMinis is an over-the-counter sleep aid indicated for the relief of occasional sleeplessness. The product contains diphenhydramine hydrochloride, an antihistamine that reduces histamine levels in the body and is commonly used to induce drowsiness. Pharmacists should check their inventory for the affected lots and advise patients accordingly, particularly those relying on this product for sleep support.