The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1523-2019·Announced 2019-07-31

Gericare Iron Supplement Elixir Recalled for Potential Microbial Contamination

Geritrex, LLC is recalling Gericare Iron Supplement Elixir due to cGMP deviations that may have resulted in microbial contamination.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (potential microbial contamination) where injury has not yet been reported, which aligns with the 'High' severity criteria.

Plain-English summary

Geritrex, LLC is voluntarily recalling 3,789 bottles of Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL). The product is identified by Lot # 70601 and an expiration date of 6/19. It was distributed nationwide in the United States by Geri-care Pharmaceuticals Corp.

The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations. These deviations indicate that the products may have microbial contamination. The source text does not report any specific illnesses or injuries associated with this recall.

Consumers who have this product should stop using it and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16
Manufacturer
Geritrex, LLC
Category
Drug — Supplement
Hazard
Affected units
3,789

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 (2)

  • Lot #: 70601
  • Exp 6/19

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Geritrex, LLC 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 8 products in this recall →

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