Nitroglycerin recalls

The FDA has published 13 recalls involving Nitroglycerin since 2014. The latest was reported on 26 Aug 2026. Most were for potency & assay. Advanced Pharma 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 recalls13since 2014

Last 12 months1reported

Class I431% of total

Ongoing3latest 26 Aug 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 2 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 1Aug 0 0

Severity split

Class I 4 31%Class II 9 69%Class III 0 0%

Why nitroglycerin is recalled

Companies

Brands

By year

202618%
2025215%
202218%
202118%
2017754%
201418%

Ongoing nitroglycerin recalls

3 active

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Drug	CLASS II	Nitroglycerin injection, USP, 50 mg/ (5 mg/mL) recalledNitroglycerin	American Regent	Particulate Matter	Nationwide
16 Apr 2025Drug	CLASS II	Nitroglycerin Sublingual Tablets 0.3MG recalledNitroglycerin	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Nitroglycerin Sublingual Tablets 0.4MG recalledNitroglycerin	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide

All nitroglycerin recalls, newest first

13 total

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Drug	CLASS II	Nitroglycerin injection, USP, 50 mg/ (5 mg/mL) recalledNitroglycerin	American Regent	Particulate Matter	Nationwide
16 Apr 2025Drug	CLASS II	Nitroglycerin Sublingual Tablets 0.3MG recalledNitroglycerin	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Nitroglycerin Sublingual Tablets 0.4MG recalledNitroglycerin	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
19 Jan 2022Drug	CLASS II	Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays recalledNitroglycerin Lingual	Padagis US	Other	Nationwide
2 Jun 2021Drug	CLASS II	Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only recalledRectiv	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
27 Dec 2017Drug	CLASS I	NitroGlycerin 1 mg/ in 5% Dextrose Inj, USP QS recalled	Advanced Pharma	Potency & Assay	Nationwide
27 Dec 2017Drug	CLASS II	NitroGlycerin (1 mg/ 1 mg in 5% Dextrose Inj, USP QS recalled	Advanced Pharma	Potency & Assay	Nationwide
27 Dec 2017Drug	CLASS I	NitroGlycerin (2 mg/ in 5% Dextrose Inj, USP QS recalled	Advanced Pharma	Potency & Assay	Nationwide
27 Dec 2017Drug	CLASS II	NitroGlycerin 1 mg/ in 5% Dextrose Inj, USP QS recalled	Advanced Pharma	Potency & Assay	Nationwide
27 Dec 2017Drug	CLASS II	NitroGlycerin 100 mcg/mL QS 5% Dextrose Inj recalled by Advanced Pharma	Advanced Pharma	Potency & Assay	Nationwide
27 Dec 2017Drug	CLASS I	NitroGlycerin (1 mg/ 1 mg in 5% Dextrose Inj, USP QS recalled	Advanced Pharma	Potency & Assay	Nationwide
27 Dec 2017Drug	CLASS II	NitroGlycerin (2 mg/ in 5% Dextrose Inj, USP QS recalled	Advanced Pharma	Potency & Assay	Nationwide
12 Feb 2014Drug	CLASS I	50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL) recalledNitroglycerin In Dextrose	Baxter Healthcare	Particulate Matter	Nationwide

Should you stop taking Nitroglycerin?

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.