Pfizer Recalls Advil PM Caplets Due to Low Diphenhydramine Levels
Pfizer is recalling 70,704 bottles of Advil PM caplets nationwide because the diphenhydramine citrate content was found to be out of specification.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Pfizer US Pharmaceutical Group is recalling 70,704 bottles of Advil PM Caplets (Ibuprofen, 200 mg / Diphenhydramine citrate, 38 mg) 120 count. The product is identified by NDC 0573-0164-43 and code G85041. The recall is being conducted because the lot produced out-of-specification test results for Diphenhydramine citrate, indicating the drug is subpotent.
The affected product was distributed nationwide. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers who have this product should stop using it and contact their pharmacist or the manufacturer for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- ADVIL PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN)
- Brand
- ADVIL PM
- Manufacturer
- Pfizer Us Pharmaceutical Group
- Category
- Drug — OTC Analgesic
- Hazard
- Affected units
- 70,704
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- G85041
Distribution
Distributed nationwide across the United States.
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