Methylcobalamin Injection Recalled Due to Sterility Assurance Concerns
Well Care Compounding Pharmacy is recalling Methylcobalamin 1 mg/mL vials because FDA inspections found GMP violations that may impact product sterility.
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 risk of serious injury or death from infection, meeting the criteria for a Severe rating.
Plain-English summary
Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling Methylcobalamin 1 mg/mL, packaged in 1 mL and 5 mL vials. The recall involves 869 units distributed in Nevada. The product is prescription-only.
The recall was initiated because FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The agency classification for this recall is Class II.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for instructions on return or replacement.
The recalled product
- Product
- METHYLCOBALAMIN 1 MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Manufacturer
- Well Care Compounding Pharmacy
- Category
- Drug — Injectable
- Affected units
- 869
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 (11)
- Lot #: 01062016: 32@16
- Exp.04/06/2016
- Lot #: 01252016: 96@51
- Exp. 07/23/2016
- Lot #: 03302016: 68@42
- Exp. 09/25/2016
- Lot #: 04042016:11@27
- Exp.10/02/2016
- Lot #: 04122016: 90@15
- Exp. 10/09/2016 04202016:57@13
- Exp.10/22/2016.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 51 recalled by Well Care Compounding Pharmacy 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 51 products in this recall →Related recalls
Same manufacturer · Well Care Compounding Pharmacy
See all →- SeverePhosphatidylcholine/Deoxycholic Acid Injection Recalled for Sterility Concerns
FDA (Drugs) · 2016-06-15
- HighFDA Recalls Itraconazole Nasal Spray Due to Sterility Concerns
FDA (Drugs) · 2016-06-15
- ModerateWell Care Compounding Pharmacy Recalls Methylcobalamin Vials for Sterility Concerns
FDA (Drugs) · 2016-06-15
- HighWell Care Compounding Pharmacy Recalls Sterility-Compromised Glutathione Vials
FDA (Drugs) · 2016-06-15
- SevereGentamicin Ophthalmic Solution Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2016-06-15
Same hazard · sterility
See all →- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- SevereMethylcobalamin Injectable Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereMethylcobalamin Injectable Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereMethylcobalamin Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2015-09-23
- SevereMethylcobalamin Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2015-09-23
- SevereLa Vita Compounding Pharmacy Recalls Methylcobalamin Injections Due to Sterility Concerns
FDA (Drugs) · 2018-07-25
- SevereMethylcobalamin Injection Recalled for Sterility Assurance Deficiency
FDA (Drugs) · 2021-11-03