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Verified · FDAClass II — Possible RiskMedications

NYSTATIN Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Indust Recall 2026

NYSTATINIssued September 14, 2026

NYSTATIN Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761; Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-1289 — recalled per FDA on 9/14/2026. Reason: Failed Stability Specifications.

What to do about this recall

Agency
FDA
Issued
Sep 14, 2026
Brand
NYSTATIN
Distribution
1 states
Lots affected
3
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

Verified summary of the official U.S. Food and Drug Administration notice · Issued September 14, 2026 · Last synced Oct 12, 2026View on fda.gov

What's recalled

Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761; Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-1289-1

Why it was recalled

Failed Stability Specifications

Affected products & lot numbers
3 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
LOT AD49605
LOT AD49606
Exp. 05/31/2027
Where was it sold
1 state

U.S. Nationwide.

nationwide
View official FDA notice
More recalls like this
4 related — by brand, contaminant, and category

Frequently asked questions

Is the NYSTATIN recall still active?

Yes, this recall is currently active as of September 14, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: LOT AD49605, LOT AD49606, Exp. 05/31/2027. Check the label on your product.

What should I do if I have the recalled NYSTATIN?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.