Leader Liquid Vitamin D Supplement Recalled for B. cepacia Contamination
Leader Liquid Vitamin D Supplement for Breastfed Infants is being voluntarily recalled due to possible contamination with B. cepacia, which may cause serious infections in vulnerable patients.
The agency’s classification
FDA (Food): 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 agency classification is FDA Class II, and the source text explicitly states the contamination may result in serious infections that could be life-threatening, meeting the criteria for a Severe rating.
Plain-English summary
The Harvard Drug Group, along with Leader Brand and Major Pharmaceuticals, is voluntarily recalling Leader Liquid Vitamin D Supplement for Breastfed Infants, 1 T oz (50 mL). The recall is being initiated due to possible product contamination with B. cepacia.
The source text states that B. cepacia may result in serious infections that could be life-threatening in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. The recall covers 1,728 units of the product, identified by UPC Number 0 96295 12862 8, across all unexpired lots.
The product was distributed nationwide in the United States. Consumers should stop using the product and follow instructions from the recalling firm or the FDA regarding disposal or return.
The recalled product
- Product
- Leader Liquid Vitamin D Supplement for Breastfed Infants, 1 T oz (50 mL)
- Manufacturer
- The Harvard Drug Group
- Category
- Food — Dietary Supplement
- Affected units
- 1,728
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)
- Leader Liquid Vitamin D Supplement for Breastfed Infants
- 1 T oz (50 mL)
- UPC Number: 0 96295 12862 8
- All Unexpired Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by The Harvard Drug Group under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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