Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Sep 21, 2018 (8 years ago)

Nystatin and Triamcinolone Acetonide Cream

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.

Cause type: Stability / shelf life

The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.

What was recalled

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

Affected NDCs 43598-0431-30 43598-0431-44 43598-0431-60

Compare with the code on your package — it is the most precise check available.

Drug: Triamcinolone

Recalling firm
Dr. Reddy's Laboratories, Inc.
NDC code
43598-431-44
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0007-2019 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Triamcinolone recalls

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Testosterone 100mg

Presence of Foreign substance - potential presence of metal particulate matter

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Other recalls by Dr. Reddy's Laboratories, Inc.

All 2018 recalls
Class III · Low risk

Varenicline Tablets

Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

Ongoing Wrong potency / content Dr. Reddy's Laboratories, Inc. NDC 43598-908-56 D-0219-2026
Class II · Moderate risk

Omeprazole Delayed-release Capsules

Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.

Ongoing Particulate / foreign matter Dr. Reddy's Laboratories, Inc. NDC 82009-022-10 D-0525-2025
Class I · High risk

Levetiracetam 0.75% in Sodium Chloride Injection 1

LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.

Ongoing Labeling / mix-up Dr. Reddy's Laboratories, Inc. NDC 43598-636-52 D-0365-2025