Class II · ModerateRecall completed
Acetaminophen Oral Solution 160 mg / 5 mL
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot# 20078A, 20083A EXP Aug. 2022; 20092A, EXP Sep. 2022; 21058A, 21048C, EXP May. 2023; 21063C, EXP Jun. 2023; 21093B, EXP Sep. 2023; 22001C, EXP Jan. 2024; 22017A, EXP Mar. 2024.
Where it was soldDistributed Nationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | Plastikon Healthcare LLC |
| NDC | 0904-6738-70 |
Show the full FDA record
| Full product label | Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6738-70 |
| Recalling firm | Plastikon Healthcare LLC |
| Distribution | Distributed Nationwide in the USA |
| Quantity | 290,270 cups |
| Recall initiated | 2022-06-07 |
| Report date | 2022-09-14 |
| Recall completed | 2025-06-25 |
| Recall number | D-1484-2022 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Lawrence KS United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.