Estradiol Pellets Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Estradiol 50 mg sterile pellets because FDA inspections found GMP violations that may impact sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving potential sterility failures in sterile products are categorized as Severe (Score 4) due to the risk of serious injury or infection, even if specific hospitalization reports are not yet detailed in the source text.
Plain-English summary
The Compounding Pharmacy of America, Inc. is recalling Estradiol 50 mg, Sterile Pellets. The recall was initiated after FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The affected product consists of 96 pellets per package. The recall covers all lots distributed nationwide between November 2014 and May 2015. Specific lot codes and dates include 11212014@11, 5/20/2015; 02092015@42, 8/8/2015; 02252015@76, 7/1/2015; and 04072015@35, 10/4/2015.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Estradiol 50 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Sterile Pellets
- Affected units
- 96
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- All lots distributed between November 2014 and May 2015
- 11212014@11
- 5/20/2015
- 02092015@42
- 8/8/2015
- 02252015@76
- 7/1/2015
- 04072015@35
- 10/4/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 382 recalled by The Compounding Pharmacy of America under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 382 products in this recall →Related recalls
Same manufacturer · The Compounding Pharmacy of America
See all →- CriticalFDA Recalls Non-Sterile HCG and Methylcobalamin Injection Vials
FDA (Drugs) · 2018-02-21
- SevereFDA Recalls Morphine and Ropivacaine Compounded Solution Due to Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereHydromorphone Solution Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereMorphine and Bupivacaine Solution Recalled for Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereMethylcobalamin Injectable Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
Same hazard · sterility failure
See all →- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereTransvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode Recalled
FDA (Devices) · 2026-07-22
- SevereArterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22