Methylcobalamin Injectable Recalled Due to Sterility Assurance Failure
Talon Compounding Pharmacy is recalling Methylcobalamin 5MG/ML injectable (Lot 07162021:70) distributed nationwide because the manufacturer cannot assure sterility of the product.
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: This is an FDA Class II recall of a sterile injectable pharmaceutical product where sterility cannot be assured. Lack of sterility in injectable drugs poses significant risk of serious infection or adverse health consequences and meets the criterion for Severe classification.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Methylcobalamin 5MG/ML (5000MCG/ML) injectable vials due to lack of assurance of sterility. The product is an Rx-only injectable preparation manufactured and distributed from the pharmacy's location in San Antonio, Texas.
The recall affects product with Lot number 07162021:70 (Beyond Use Date 10/14/2021) that was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
Consumers and healthcare providers who have received this product should not use it and should contact the recalling firm for instructions on return or destruction. Patients who have received injections from affected vials should consult their healthcare provider regarding potential exposure.
The recalled product
- Product
- METHYLCOBALAMIN 5MG/ML (5000MCG/ML) INJ 5MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Manufacturer
- Vita Pharmacy, LLC dba Talon Compounding Pharmacy
- Hazard
- sterility-assurance-failure
- contamination-risk
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)
- Lot: 07162021:70 BUD: 10/14/2021
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-06-17
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- SevereCIMZIA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-05-27