CLASS I Food recall · Reported 19 Aug 2020 · FDA Enforcement Report

Iron (III) Hydroxide Polysaccharides Complex in polyethylene drums recalled

Advanced Compounds International is recalling Iron (III) Hydroxide Polysaccharides Complex in polyethylene drums, distributed in Nebraska, New Jersey. The recall was initiated on 24 Jul 2020 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesBATCH NO. PIC/B181008; MFG DT.L FEB 2018; EXP. DT.: JAN-2021; BATCH NO.: PIC/B181007, MFG. DT.: FEB 2018, EXP.DT.: JAN 2021; BATCH NO.: PIC/B171001, MFG. DT. OCT 2017, EXP. DT. SEP 2020
Quantity recalled60 drums (25Kg/drum); 1500Kg total

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

Recall details

Recall number
F-1150-2020
FDA event ID
86111
Recalling firm
Advanced Compounds International, Nanuet, NY
Brand
Iron
Classification
Class I
Status
Terminated
Recall initiated
24 Jul 2020
FDA classified
10 Aug 2020
Reported
19 Aug 2020
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Undeclared Milk
Product category
Tea

Timeline

24 Jul 2020Recall initiated by company
10 Aug 2020Classified by FDA+17 days
19 Aug 2020Published in enforcement report+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Product contains undeclared milk allergen.

Product as listed by the FDA

Iron (III) Hydroxide Polysaccharides Complex in 25kg polyethylene drums manufactured by Chaitanya Biologicals Pvt. Ltd, Buldhana, India

Where it was distributed

NJ, NE

NebraskaNew Jersey

Questions about this recall

Is Iron (III) Hydroxide Polysaccharides Complex in polyethylene drums recalled?

Yes. Advanced Compounds International recalled Iron (III) Hydroxide Polysaccharides Complex in polyethylene drums on 24 Jul 2020. The recall is Class I and its status is Terminated. Recall number F-1150-2020.

Why was it recalled?

Product contains undeclared milk allergen.

Which lots are affected?

BATCH NO. PIC/B181008; MFG DT.L FEB 2018; EXP. DT.: JAN-2021; BATCH NO.: PIC/B181007, MFG. DT.: FEB 2018, EXP.DT.: JAN 2021; BATCH NO.: PIC/B171001, MFG. DT. OCT 2017, EXP. DT. SEP 2020

Where was it sold?

NJ, NE

What should I do if I have it?

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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