Western Drug Recalls Dep-Estradiol Injection Due to Sterility Concerns
Western Drug is recalling Dep-Estradiol 10 mg/mL Injection because the company cannot ensure the product is sterile. The recall covers 9 containers distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of infection associated with non-sterile injectable drugs.
Plain-English summary
Western Drug Inc. is recalling 9 containers of Dep-Estradiol 10 mg/mL Injection, a prescription medication. The recall is being conducted because the company lacks assurance of the product's sterility. The affected product is distributed nationwide in the United States, specifically in Arizona, California, Georgia, New Mexico, South Carolina, South Dakota, Texas, and Utah.
The recall covers all lots of the product. Consumers and healthcare providers should stop using the recalled medication and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Dep-Estradiol 10 mg/mL Injection, Rx, Western Drug Inc. 106 E. Main Street, Springerville, Arizona 85938
- Manufacturer
- Western Drug
- Category
- Drug — Injectable
- Affected units
- 9
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 (1)
- all lots
Distribution
Part of a larger recall action
This product is one of 91 recalled by Western Drug 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 91 products in this recall →Related recalls
Same manufacturer · Western Drug
See all →- SevereWestern Drug Recalls Sodium Hydroxide 10% Injection Due to Sterility Concerns
FDA (Drugs) · 2015-12-09
- SevereWestern Drug Recalls Methylcobalamin Injection Due to Sterility Concerns
FDA (Drugs) · 2015-12-09
- SevereWestern Drug Recalls Benadryl Injection Due to Sterility Concerns
FDA (Drugs) · 2015-12-09
- SevereWestern Drug Recalls PZI 40 Insulin Due to Sterility Concerns
FDA (Drugs) · 2015-12-09
- SevereWestern Drug Recalls Ketorolac Injection Due to Sterility Concerns
FDA (Drugs) · 2015-12-09
Same hazard · infection
See all →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
Similar recalls
- SevereDowning Labs Recalls Dexpanthenol Injection Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- SevereDowning Labs Recalls Co-Enzyme Q-10 Injectable Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- SevereDexpanthenol Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2018-11-07
- SevereDowning Labs Recalls TNPRDC Injection Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- SevereDowning Labs Recalls B12 Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-11-25
- SevereDowning Labs Recalls Pyridoxine Injection Due to Sterility Concerns
FDA (Drugs) · 2015-11-25