Severity
Moderate
FDA Drug recall · Reported January 19, 2022
Defective Delivery System
Padagis US LLC recalled Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only… - a moderate-severity action.
Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only… was recalled by Padagis US LLC in January 19, 2022. Reason: Defective Delivery System. Check the official notice for the remedy. Verify recall #D-0372-2022 with the FDA Drug before acting.
The recall
Padagis US LLC issued this moderate-severity FDA Drug recall-Defective Delivery System.
Sourced from official FDA Drug enforcement records. Verify recall #D-0372-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-0372-2022) was formally reported on January 19, 2022, with the manufacturer initiating the action on December 27, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Padagis US LLC is listed as the recalling firm, operating out of Minneapolis, MN. Federal records list the affected scope as 11,868 bottles.
The documented reason for this recall is: Defective Delivery System Distribution data in the federal record shows the product reached: Nationwide USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
11,868 bottles
Related Recalls
6
5 from same agency
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
Defective Delivery System
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0372-2022 |
| Date reported | January 19, 2022 |
| Date initiated | December 27, 2021 |
| Recalling firm | Padagis US LLC |
| Firm location | Minneapolis, MN |
| Affected scope | 11,868 bottles |
| Distribution | Nationwide USA |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
AbbVie Inc. · 2026-06-03
Llorens Pharmaceuticals International Division, Inc. · 2026-05-27
Safecor Health, LLC · 2026-05-27
IntegraDose Compounding Services LLC · 2026-05-27
Lupin Pharmaceuticals Inc. · 2026-05-27
Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported January 19, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.