AvKARE fludrocortisone tablets recalled over impurity levels
AvKARE is recalling one lot of fludrocortisone acetate 0.1 mg tablets because testing found impurity or degradation levels above required limits. The recall covers lot 48353 (expiration 10/31/2026) in 50-tablet unit-dose cartons, NDC 50268-330-15, distributed nationwide. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All AvKARE recalls
What to do
- Check whether your carton has lot 48353, expiration 10/31/2026, and NDC 50268-330-15.
- Do not stop taking this medication without first talking to your prescriber, since abrupt changes can be harmful.
- Contact your pharmacist or prescriber to arrange a replacement supply, as no remedy has been specified.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 50 Tablets (5 x 10) Unit Dose AVPAK, Manufactured for: AvKARE, Pulaski, TN 38748, NDC 50268-330-15
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 8866 cartons
- Illnesses reported
- None reported
- Manufactured in
- 615 N 1st St, Pulaski, Tennessee, United States
- Classification
- Class II
- Recall number
- D-0157-2027
In the FDA's words
- Description
- Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 50 Tablets (5 x 10) Unit Dose AVPAK, Manufactured for: AvKARE, Pulaski, TN 38748, NDC 50268-330-15 Failed Impurities/Degradation Specifications Lot # 48353; Exp. 10/31/2026 Distribution: U.S. Nationwide Affected quantity: 8866 cartons
- Hazard
- Failed Impurities/Degradation Specifications
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