Promethazine recalls

The FDA has published 4 recalls involving Promethazine since 2014. The latest was reported on 7 Jun 2023. Most were for potency & assay. Zydus Pharmaceuticals USA 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 recalls4since 2014

Last 12 months0reported

Class I00% of total

Ongoing1latest 7 Jun 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 4 100%Class III 0 0%

Why promethazine is recalled

Companies

Zydus Pharmaceuticals USA125%
Duren Health Mart Pharmacy125%
Mckesson Medical-Surgical Inc. Corporate Office125%
Akorn125%

By year

2023125%
2022125%
2019125%
2014125%

Ongoing promethazine recalls

1 active

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Drug	CLASS II	Promethazine HCl Oral Solution, USP, 25 mg recalled by Akorn	Akorn	Potency & Assay	Nationwide

All promethazine recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Drug	CLASS II	Promethazine HCl Oral Solution, USP, 25 mg recalled by Akorn	Akorn	Potency & Assay	Nationwide
15 Jun 2022Drug	CLASS II	Promethazine HCl Tablets, USP, 25 mg unit dose recalled	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
6 Feb 2019Drug	CLASS II	Promethazine Gel 50 mg/mL, 1cc to 10cc per prescription recalled	Duren Health Mart Pharmacy	Foreign Material	TN
28 May 2014Drug	CLASS II	Promethazine Hydrochloride Tablets, USP, 25 mg recalledPromethazine Hydrochloride	Zydus Pharmaceuticals USA	Other	Nationwide

Should you stop taking Promethazine?

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.