Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP deviations
Legatrin PM Pain Reliever/Sleep Aid (acetaminophen 500 mg, diphenhydramine HCl 50mg caplets) 50-count bottles, Manufactured for: Church & Dwight Co., Inc. Ewing, NJ 08628 NDC 10237-907-50
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Reason Defective Container
Reason Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine…
Reason Discoloration
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.