Cimetidine recalls
The FDA has published 2 recalls involving Cimetidine since 2021. The latest was reported on 7 Jun 2023. Most were for manufacturing (cgmp) deviations. 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 2021
Last 12 months0reported
Class I00% of total
Ongoing1latest 7 Jun 2023
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 cimetidine is recalled
Companies
By year
Ongoing cimetidine recalls
1 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cimetidine HCl Oral Solution 300mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
All cimetidine recalls, newest first
2 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cimetidine HCl Oral Solution 300mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Cimetidine Hydrochloride Oral Solution 300 mg recalled by PAI Holdings | PAI Holdings | Manufacturing (CGMP) Deviations | Nationwide |
Should you stop taking Cimetidine?
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.