Pallimed Solutions Recalls Testosterone Injections Due to Sterility Concerns
Pallimed Solutions is recalling Testosterone Cypionate/Enanthate injections nationwide due to FDA inspectional findings regarding sterility assurance and quality control.
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 and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
Pallimed Solutions Pharmacy in Woburn, Massachusetts, is recalling Testosterone Cypionate/Testosterone Enanthate Injection. The recall is being conducted due to FDA inspectional findings that raised concerns about quality control procedures impacting the assurance of sterility for the compounded product.
The recall covers all lots within their expiry dates and is distributed nationwide. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected injections and contact their healthcare provider or the recalling firm for further instructions on disposal or replacement.
The recalled product
- Product
- Testosterone Cypionate/Testosterone Enanthate Injection, compounded by Pallimed Solutions Pharmacy, Woburn, MA
- Manufacturer
- Pallimed Solutions
- Category
- Drug — Injectable Steroids
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 within expiry
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by Pallimed Solutions 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 25 products in this recall →Related recalls
Same manufacturer · Pallimed Solutions
See all →- SeverePallimed Solutions Recalls Atropine Injection Due to Sterility Concerns
FDA (Drugs) · 2013-08-21
- SeverePallimed Solutions Recalls Trimix Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2013-08-21
- SevereQuadmix Injection Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2013-08-21
- SeverePallimed Acetylcysteine Ophthalmic Solution Recalled for Sterility Concerns
FDA (Drugs) · 2013-08-21
- SeverePallimed Solutions Recalls Testosterone Injection Due to Sterility Concerns
FDA (Drugs) · 2013-08-21
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- 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
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- SevereEssential Wellness Recalls Testosterone Cypionate Injection Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- SevereTestosterone Cypionate Injection Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereTestosterone Cypionate Injection Recalled Due to Sterility Concerns
FDA (Drugs) · 2015-09-23
- SevereTestosterone Cypionate Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereTestosterone Cypionate Injectable Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereTestosterone Cypionate Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2015-09-23