CLASS II Drug recall · Reported 19 Jan 2022 · FDA Enforcement Report
Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays recalled
Padagis US is recalling Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, distributed nationwide in the US. The recall was initiated on 27 Dec 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0372-2022
- FDA event ID
- 89310
- Recalling firm
- Padagis US, Minneapolis, MN
- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Dec 2021
- FDA classified
- 13 Jan 2022
- Reported
- 19 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
Timeline
| 27 Dec 2021 | Recall initiated by company | |
| 13 Jan 2022 | Classified by FDA | +17 days |
| 19 Jan 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Delivery System
Product as listed by the FDA
Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufactured by Perrigo, Yeruham, Israel; Distributed by Perrigo, Allegan, MI 49010, NDC 45802-210-02
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
Defective Delivery System
Which lots are affected?
Lot, expiry: Lot 150892, exp Oct 2022; Lot 153199, exp Feb 2023; Lot 156041, exp Apr 2023
Where was it sold?
Nationwide USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Nitroglycerin recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nitroglycerin injection, USP, 50 mg/ (5 mg/mL) recalledNitroglycerin | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Nitroglycerin Sublingual Tablets 0.3MG recalledNitroglycerin | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nitroglycerin Sublingual Tablets 0.4MG recalledNitroglycerin | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only recalledRectiv | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS I | NitroGlycerin 1 mg/ in 5% Dextrose Inj, USP QS recalled | Advanced Pharma | Potency & Assay | Nationwide |