Perrigo recalls infant grape-flavored acetaminophen suspension due to contaminated excipient from supplier. Products distributed by Wal-Mart with specific NDC and batch numbers. Consumers should check labels and contact Perrigo for details.
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Perrigo is recalling infant grape-flavored acetaminophen oral suspension because it was made with a contaminated ingredient. This could pose a health risk to babies if they consume the product.
The product was manufactured using an excipient (a substance added to the medication) that was contaminated. This contamination could lead to health issues if the infant consumes the product, though the exact risk is not specified in the recall notice.
Parents or caregivers of infants who own the recalled product. Infants are at highest risk due to their small body size and sensitivity to medication.
Check for the product name 'Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle'. Look for NDC code 49035-946-16 and batch numbers 1FK1027, 1FK1184, or 1EK1046 that expire by 02/28/2023.
Look for the NDC code 49035-946-16 and batch numbers 1FK1027, 1FK1184, or 1EK1046 on the bottle.
The recall states the product was manufactured with a contaminated excipient, but the exact health risk is not specified. Do not use the product until you confirm it's not recalled.
Check the product label for NDC code 49035-946-16 and batch numbers 1FK1027, 1FK1184, or 1EK1046 that expire by 02/28/2023.
The recall does not specify a remedy, so contact Perrigo directly for instructions on what to do with the product.
We’ve drafted a message you can send Perrigo to request your refund or repair — edit it as you like.
Subject: Recall D-0598-2022 — Perrigo Perrigo Hello, I own a Perrigo that is covered by recall D-0598-2022 from Perrigo. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
