The Recall Desk
SevereFDA (Food)·F-3526-2017·Announced 2017-09-20

Voluntary Recall of Major Ferrous Drops Due to B. cepacia Contamination

The Harvard Drug Group is voluntarily recalling Major Ferrous Drops due to possible B. cepacia contamination, which poses a serious infection risk to vulnerable patients.

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 agency classified this as an FDA Class II recall, 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 distribution firms Leader Brand and Major Pharmaceuticals, is voluntarily recalling Major Ferrous Drops, 1 2/3 oz (50 mL). The recall involves 63,005 units of the product, which is identified by UPC Number 3 09046 27350 9 and includes all unexpired lots.

The recall is being initiated due to possible product contamination with B. cepacia. This bacterium 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 product was distributed nationwide in the United States. Consumers should check their inventory for this specific product and discontinue use if they are in the affected population groups mentioned in the recall notice.

The recalled product

Product
Major Ferrous Drops, 1 2/3 oz (50 mL)
Manufacturer
The Harvard Drug Group
Category
Food — Dietary Supplement
Hazard
Affected units
63,005

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 Ferrous 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

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Same hazard · b cepacia

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