Acetaminophen & Codeine recalls

The FDA has published 2 recalls involving Acetaminophen & Codeine since 2016. The latest was reported on 7 Jun 2023. Most were for foreign material. Akorn has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls2since 2016
Last 12 months0reported
Class I00% of total
Ongoing1latest 7 Jun 2023

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 1 50%Class III 1 50%

Why acetaminophen & codeine is recalled

By year

Ongoing acetaminophen & codeine recalls

1 active
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIAcetaminophen & Codeine Phosphate Oral Solution 120mg/12mg recalledAkornPotency & AssayNationwide

All acetaminophen & codeine recalls, newest first

2 total

Should you stop taking Acetaminophen & Codeine?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.