FDA recall, , Moderate risk
AvKARE Fludrocortisone Acetate Tablets
Avkare Fludrocortisone Acetate Tablets, USP 0.1mg may contain more impurities than allowed.
Summary by Recall Canary from the FDA notice
What happened
AvKARE of Pulaski, Tennessee, voluntarily recalled Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 50 Tablets (5 x 10) Unit Dose AVPAK, because the product failed impurities and degradation specifications. The recall, which the company began on October 9, 2026, was added to the FDA's Enforcement Report on October 30, 2026. The tablets were distributed nationwide in the U.S.
Customers were notified by letter. The recall was classified by the FDA on October 30, 2026.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Fludrocortisone Acetate Tablets, USP 0.1mg
- NDC
- 50268-330-15
- Lot code
- 48353
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Oct 26, 2026
- Sold in
U.S. Nationwide
- Recalled by
- AvKAREPulaski, Tennessee
- Hazard
- Drug impurity
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 100126
- Recall number
- D-0157-2027
- Quantity recalled
- 8866 cartons
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
AvKARE began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
