Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported November 30, 2016
KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, Rx only, RANBAXY, Jacksonville, FL 32257, UPC 3 10631 09335 8.
Failed Stability Specifications: Low Out of Specification results for alcohol content.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Sun Pharmaceutical Industries, Inc. recalled KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g… - a low-severity action.
KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g… was recalled by Sun Pharmaceutical Industries, Inc. in November 30, 2016. Reason: Failed Stability Specifications: Low Out of Specification results for alcohol content.. Check the official notice for the remedy. Verify recall #D-0148-2017 with the FDA Drug before acting.
The recall
Sun Pharmaceutical Industries, Inc. issued this low-severity FDA Drug recall-Failed Stability Specifications: Low Out of Specification results for alcohol content..
- Low
- severity level
- Class III
- classification
- November 30, 2016
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0148-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0148-2017) was formally reported on November 30, 2016, with the manufacturer initiating the action on October 28, 2016. It is classified under Low severity (Class III), with a current status of Terminated. Sun Pharmaceutical Industries, Inc. is listed as the recalling firm, operating out of Cranbury, NJ. Federal records list the affected scope as 326,103 bottles.
The documented reason for this recall is: Failed Stability Specifications: Low Out of Specification results for alcohol content. Distribution data in the federal record shows the product reached: NJ and further distributed 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 - 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.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products 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.
Affected scope
326,103 bottles
Related Recalls
6
0 from same agency
Product description
KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, Rx only, RANBAXY, Jacksonville, FL 32257, UPC 3 10631 09335 8.
Reason for recall
Failed Stability Specifications: Low Out of Specification results for alcohol content.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0148-2017 |
| Date reported | November 30, 2016 |
| Date initiated | October 28, 2016 |
| Recalling firm | Sun Pharmaceutical Industries, Inc. |
| Firm location | Cranbury, NJ |
| Affected scope | 326,103 bottles |
| Distribution | NJ and further distributed 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.
- Check the recall number (D-0148-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
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.
Frequently Asked Questions
What product was recalled? ▼
KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, Rx only, RANBAXY, Jacksonville, FL 32257, UPC 3 10631 09335 8.. Recalled by Sun Pharmaceutical Industries, Inc.. Units affected: 326,103 bottles.
Why was this product recalled? ▼
Failed Stability Specifications: Low Out of Specification results for alcohol content.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 30, 2016. Severity: Low. Recall number: D-0148-2017.
Where was the recalled product distributed? ▼
Distribution: NJ and further distributed Nationwide in the USA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0148-2017) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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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 November 30, 2016. 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.