The Recall Desk
Agency classClass IIOur severity:SevereFDA (Food)·F-3525-2017·Announced 2017-09-20

Major D-Vita Drops Recalled for Possible B. cepacia Contamination

The Harvard Drug Group is voluntarily recalling Major D-Vita Drops due to possible B. cepacia contamination, 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 Major D-Vita Drops, 1 2/3 oz (50 mL). The recall involves 27,447 units of the product, which is identified by UPC Number 3 09046 27350 9. All unexpired lots are affected.

The recall is being initiated because the supplements may be contaminated with B. cepacia. This contamination may result in serious infections that could be life-threatening for patients with compromised immune systems and for patients with chronic lung conditions such as cystic fibrosis.

The product was distributed nationwide in the United States. No foreign distribution is reported. Consumers should check their inventory for this specific product and UPC number. If found, they should stop using the product and follow the instructions provided by the recalling firm or the FDA.

The recalled product

Product
Major D-Vita Drops, 1 2/3 oz (50 mL)
Manufacturer
The Harvard Drug Group
Category
Food — Dietary Supplement
Hazard
Affected units
27,447

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)

  • Major D-Vita Drops
  • 1 2/3 oz (50 mL)
  • UPC Number:3 09046 27350 9
  • 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.

See all 17 products in this recall →

Related recalls

Same manufacturer · The Harvard Drug Group

See all →

Same hazard · b cepacia contamination

See all →

Similar recalls