Severity
Moderate
FDA Drug recall · Reported September 7, 2022
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Padagis US LLC recalled Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bro… - a moderate-severity action.
Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bro… was recalled by Padagis US LLC in September 7, 2022. Reason: CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.. Check the official notice for the remedy. Verify recall #D-1497-2022 with the FDA Drug before acting.
The recall
Padagis US LLC issued this moderate-severity FDA Drug recall-CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness..
Sourced from official FDA Drug enforcement records. Verify recall #D-1497-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-1497-2022) was formally reported on September 7, 2022, with the manufacturer initiating the action on August 17, 2022. 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 57,816 tubes.
The documented reason for this recall is: CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness. Distribution data in the federal record shows the product reached: Nationwide in the 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, 3 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 - 1,360 cosmetics & personal care 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
57,816 tubes
Related Recalls
6
3 from same agency
Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI 49010, NDC 45802-064-36.
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1497-2022 |
| Date reported | September 7, 2022 |
| Date initiated | August 17, 2022 |
| Recalling firm | Padagis US LLC |
| Firm location | Minneapolis, MN |
| Affected scope | 57,816 tubes |
| Distribution | Nationwide in the 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.
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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 September 7, 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.