Promethazine Plain recalls
The FDA has published 2 recalls involving Promethazine Plain since 2021. The latest was reported on 29 Sep 2021. Most were for manufacturing (cgmp) deviations. Morton Grove Pharmaceuticals 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 2021
Last 12 months0reported
Class I00% of total
Ongoing0latest 29 Sep 2021
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 2 100%Class III 0 0%
Why promethazine plain is recalled
Companies
By year
All promethazine plain recalls, newest first
2 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Promethazine Syrup Plain, 6.25 mg recalled | Morton Grove Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Promethazine Plain Oral Solution 6.25mg/; ; Rx; Solution recalled | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
Should you stop taking Promethazine Plain?
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.