The Recall Desk
ModerateFDA (Drugs)·D-0132-2017·Announced 2016-11-16

Wells Pharmacy Recalls Estradiol Pellets Due to Potency Issues

Wells Pharmacy Network is recalling Estradiol 12.5 mg Pellets because they may be superpotent or subpotent. Consumers should stop using the product.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is potency deviation, which is a quality issue rather than a direct physical or biological hazard like contamination or injury.

Plain-English summary

Wells Pharmacy Network, LLC is recalling Estradiol 12.5 mg Pellets. The recall is due to the product being superpotent or subpotent, meaning the drug concentration may be higher or lower than intended.

The affected product consists of 353 pellets, identified by Lot Number 08172016@9, with a beyond-use date of 02/13/2017. The product was distributed in the U.S.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.

The recalled product

Product
Estradiol 12.5 mg Pellet, Compounded by: Wells Pharmacy Network
Affected units
353

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 (2)

  • Lot Number 08172016@9
  • BUD: 02/13/2017

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 7 recalled by Wells Pharmacy Network, LLC 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 7 products in this recall →