Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Read the official FDA notice →What to do
Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.
Details
- Recalling company
- Padagis US LLC — Minneapolis, MN
- Severity
- Class II — moderate
- Reported
- July 22, 2026
- Quantity
- 180,936 tubes
- Recall number
- D-0677-2026
- Status
- Ongoing
- Source
- FDA
Where it went
USA Nationwide
Other medicine & devices recalls
-
Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4) 19 mcg, liothyronine (T3) 4.5 mcg, 100 Tablets, Rx only, Distributed by: Vitruvias Therapeutics,…
Class I — serious · FDA · September 23, 2026 · VITRUVIAS THERAPEUTICS INC
-
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 10…
Class I — serious · FDA · September 23, 2026 · SUN PHARMACEUTICAL INDUSTRIES INC
-
Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC:…
Class II — moderate · FDA · September 23, 2026 · Safecor Health, LLC
-
Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC:…
Class II — moderate · FDA · September 23, 2026 · Safecor Health, LLC
-
Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC:…
Class II — moderate · FDA · September 23, 2026 · Safecor Health, LLC
-
Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC:…
Class II — moderate · FDA · September 23, 2026 · Safecor Health, LLC
-
Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 0…
Class II — moderate · FDA · September 23, 2026 · Safecor Health, LLC
-
Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC:…
Class II — moderate · FDA · September 23, 2026 · Safecor Health, LLC