The Recall Desk
HighCPSC·96171·Announced 1996-07-25

CVS Sleep Caplets Recalled for Lacking Child-Resistant Packaging

PL Development is recalling 3,798 bottles of CVS Sleep Caplets because they lack required child-resistant packaging, posing a poisoning risk to children.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (toxic medication) where injury has not yet been reported, fitting the High severity criteria for theoretical hazards with potential for serious injury.

Plain-English summary

PL Development Inc. is voluntarily recalling 3,798 bottles of CVS Sleep Caplets in cooperation with the U.S. Consumer Product Safety Commission (CPSC). The recalled bottles contain diphenhydramine but lack the child-resistant packaging required by the Poison Prevention Packaging Act. Diphenhydramine is toxic if accidentally ingested by children and can cause serious injury or death.

The recalled product is labeled "CVS sleep caplets nighttime sleep aid 60 CAPLETS... Active Ingredient: Each caplet contains 25 mg. Diphenhydramine Hydrochloride." The outer boxes and bottles bear lot numbers D423 or D424. CVS sold these bottles from February 26, 1996, to March 19, 1996, for approximately $3.89 each. CVS has removed the non-compliant bottles from shelves and currently sells the product with appropriate child-resistant closures, which are not under recall.

CPSC, PL Development, and CVS are not aware of any injuries involving this product. The recall is being conducted to prevent the possibility of injury. Consumers should stop using the recalled sleep caplets immediately and return the bottle to the store where purchased for an exchange or full refund. For more information, consumers can call PL Development collect at (516) 249-0867.

The recalled product

Product
CVS Sleep Caplets
Manufacturer
CVS
Category
Drug — Sleep Aid
Hazard

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · poisoning

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