Medaus Recalls Methyl B12 Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Methyl B12 5mg/mL vials due to a lack of assurance of sterility. The product was distributed in the U.S., Japan, and New Zealand.
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. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility in an injectable product warrants a score of 4 (Severe), as it poses a risk of serious adverse health consequences.
Plain-English summary
Medaus, Inc. is recalling specific lots of Methyl B12 5mg/mL (PF) in NaCl 0.9%, 1mL vials. The recall was initiated because of a lack of assurance of sterility in the product.
The affected product includes 600 mL in vials from two specific lots: Lot #151123-25 with a beyond-use date of 05/21/16, and Lot #160126-12 with a beyond-use date of 07/24/16. The product was distributed nationwide in the United States, as well as in Japan and New Zealand.
Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled lots. No specific instructions for disposal or return are provided in the source text.
The recalled product
- Product
- METHYL B12 5MG/ML (PF) IN NACL 0.9%, 1ML Vials, MEDAUS PHARMACY
- Manufacturer
- Medaus, Inc.
- Category
- Drug — Injectable Medication
- Hazard
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 (4)
- Lot #: 151123-25
- BUD: 05/21/16
- Lot #: 160126-12
- BUD: 07/24/16
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 88 recalled by Medaus, Inc. 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 88 products in this recall →Related recalls
Same manufacturer · Medaus, Inc.
See all →- SevereMedaus Recalls Testosterone Cypionate Vials Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SevereMedaus Recalls Testosterone Cypionate Vials Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SevereMedaus Recalls Taurine Vials Due to Lack of Sterility Assurance
FDA (Drugs) · 2016-07-20
- SevereMedaus Recalls Lipo-Injection Vials Due to Sterility Assurance Concerns
FDA (Drugs) · 2016-07-20
- SevereMedaus Recalls B-Complex Vials Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
Same hazard · lack of sterility
See all →- HighRohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighRohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-07-29
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15