Severity
Low
FDA Drug recall · Reported January 14, 2015
Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.
Akorn, Inc. recalled Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC … - a low-severity action.
Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC … was recalled by Akorn, Inc. in January 14, 2015. Reason: Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stabi…. Check the official notice for the remedy. Verify recall #D-0333-2015 with the FDA Drug before acting.
The recall
Akorn, Inc. issued this low-severity FDA Drug recall-Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stabi….
Sourced from official FDA Drug enforcement records. Verify recall #D-0333-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-0333-2015) was formally reported on January 14, 2015, with the manufacturer initiating the action on December 9, 2014. It is classified under Low severity (Class III), with a current status of Terminated. Akorn, Inc. is listed as the recalling firm, operating out of Lake Forest, IL. Federal records list the affected scope as 3,937 bottles.
The documented reason for this recall is: Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point. Distribution data in the federal record shows the product reached: Nationwide. 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Low
Affected scope
3,937 bottles
Related Recalls
6
3 from same agency
Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60).
Failed Impurities/Degradation Specifications: The known impurity went out of specification at 12 months stability point.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0333-2015 |
| Date reported | January 14, 2015 |
| Date initiated | December 9, 2014 |
| Recalling firm | Akorn, Inc. |
| Firm location | Lake Forest, IL |
| Affected scope | 3,937 bottles |
| Distribution | Nationwide |
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 January 14, 2015. 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.