Cromolyn recalls

The FDA has published 2 recalls involving Cromolyn since 2023. The latest was reported on 7 Jun 2023. Most were for manufacturing (cgmp) deviations. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls2since 2023

Last 12 months0reported

Class I00% of total

Ongoing2latest 7 Jun 2023

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why cromolyn is recalled

Manufacturing (CGMP) Deviations150%
Potency & Assay150%

Companies

Akorn2100%

By year

20232100%

Ongoing cromolyn recalls

2 active

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Drug	CLASS II	Cromolyn Sodium Ophthalmic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide
25 Jan 2023Drug	CLASS II	Cromolyn Sodium Ophthalmic Solution recalled by Akorn	Akorn	Manufacturing (CGMP) Deviations	Nationwide

All cromolyn recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Drug	CLASS II	Cromolyn Sodium Ophthalmic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide
25 Jan 2023Drug	CLASS II	Cromolyn Sodium Ophthalmic Solution recalled by Akorn	Akorn	Manufacturing (CGMP) Deviations	Nationwide

Should you stop taking Cromolyn?

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.