Pallimed Methylcobalamin Recall Due to Sterility Assurance Concerns
Pallimed Solutions is recalling Methylcobalamin PF vials nationwide due to FDA inspectional findings regarding quality control and sterility assurance.
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, which corresponds to a Severe rating under the rubric, particularly given the risk of sterility failure in a compounded injectable medication.
Plain-English summary
Pallimed Solutions is recalling Methylcobalamin PF, a compounded medication available in 3-vial packages. The recall covers all lots within their expiration dates and was distributed nationwide.
The recall was initiated following FDA inspectional findings that raised concerns about quality control procedures. Specifically, the inspection identified issues that impacted the assurance of sterility for the product.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- Methylcobalamin PF, compounded by Pallimed Solutions Pharmacy, Woburn, MA
- Manufacturer
- Pallimed Solutions
- Category
- Drug — Compounded Medication
- Affected units
- 3
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 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
- SeverePallimed Recalls Nandrolone Decanoate Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-08-21
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