Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class III · Low risk Terminated Initiated Sep 19, 2016 (10 years ago)

Estradiol 12.5 mg Pellet

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Superpotent and Subpotent drugs

Cause type: Wrong potency / content

Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.

What was recalled

Estradiol 12.5 mg Pellet, Compounded by: Wells Pharmacy Network

Drug: Estradiol

Recalling firm
Wells Pharmacy Network, LLC
Origin
TN, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0132-2017 · FDA notice

Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Estradiol recalls

See all
Class II · Moderate risk

Alyacen 7/7/7

Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.

Ongoing Impurity / degradation Glenmark Pharmaceuticals Inc., USA NDC 68462-556-29 D-0588-2026
Class II · Moderate risk

Estradiol Gel

Defective Container; packets were found to be either empty or partially full.

Ongoing Packaging defect ANI Pharmaceuticals, Inc. NDC 70954-531-20 D-0543-2026
Class II · Moderate risk

Estradiol

Presence of Foreign substance - potential presence of metal particulate matter

Ongoing Particulate / foreign matter F.H. INVESTMENTS, Inc. (dba Asteria Health) D-0315-2026
Class II · Moderate risk

Estradiol

Presence of Foreign substance - potential presence of metal particulate matter

Ongoing Particulate / foreign matter F.H. INVESTMENTS, Inc. (dba Asteria Health) D-0314-2026
Class II · Moderate risk

Estradiol

Presence of Foreign substance - potential presence of metal particulate matter

Ongoing Particulate / foreign matter F.H. INVESTMENTS, Inc. (dba Asteria Health) D-0313-2026

Other recalls by Wells Pharmacy Network, LLC

All 2016 recalls