FDA Drug recall · Reported October 10, 2018
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g tube (NDC 43598-431-30), c) 60 g tube (NDC 43598-431-60), Rx only, Distributor: Dr. Reddy's Laboratories, Inc. 107 College Road East, Princeton, NJ - 08540 Rx Only Made in India
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
Dr. Reddy's Laboratories, Inc. recalled Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in … - a moderate-severity action.
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in … was recalled by Dr. Reddy's Laboratories, Inc. in October 10, 2018. Reason: Failed stability specifications - An out of specification result was observed for the test parameter : compos…. Check the official notice for the remedy. Verify recall #D-0007-2019 with the FDA Drug before acting.
The recall
Dr. Reddy's Laboratories, Inc. issued this moderate-severity FDA Drug recall-Failed stability specifications - An out of specification result was observed for the test parameter : compos….
- Moderate
- severity level
- Class II
- classification
- October 10, 2018
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0007-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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.
Cosmetics & Personal Care recalls over time
Where this recall sits in its category - 1,371 cosmetics & personal care recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
Product description
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g tube (NDC 43598-431-30), c) 60 g tube (NDC 43598-431-60), Rx only, Distributor: Dr. Reddy's Laboratories, Inc. 107 College Road East, Princeton, NJ - 08540 Rx Only Made in India
Reason for recall
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-0007-2019 |
| Date reported | October 10, 2018 |
| Date initiated | September 21, 2018 |
| Recalling firm | Dr. Reddy's Laboratories, Inc. |
| Firm location | Princeton, NJ |
| Affected scope | 35020 tubes |
| Distribution | U.S.A. 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.
- Check the recall number (D-0007-2019) 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? ▼
Why was this product recalled? ▼
Which agency issued this recall? ▼
Where was the recalled product distributed? ▼
Should I stop using a recalled medication or medical device? ▼
Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Cosmetics & Personal Care · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
Compare this recall with Ice Pop, D'Dioses Cookies Cream, 1 Bar (81.7 g), with UPC 7… → · All Cosmetics & Personal Care recalls
Methodology · Corrections · Archive as of August 2026