RIJ Pharmaceutical Gericare Iron Supplement Elixir Ferrous Recall

Why it was recalled

CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

Product description

Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz. (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16, UPC 57896709167

Lot numbers, UPCs & expiration codes

Lot #: 4780111, Exp. 08/19

Where it was sold

Nationwide in the USA

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0853-2018
Classification: Class II
Status: Terminated
Recall initiated: May 7, 2018
FDA report date: Jun 20, 2018
Quantity: 8124 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: RIJ Pharmaceutical LLC

Original FDA data

Every field from FDA enforcement report D-0853-2018, exactly as published.

Show all FDA fields

City: Middletown
State: NY
Status: Terminated
Country: United States
Event ID: 80053
Address: 40 Commercial Ave
Code information: Lot #: 4780111, Exp. 08/19
Postal code: 10941-1444
Report date: Jun 20, 2018
Product type: Drugs
Recall number: D-0853-2018
Classification: Class II
Recalling firm: RIJ Pharmaceutical LLC
Product quantity: 8124 bottles
Termination date: Apr 7, 2023
Reason for recall: CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz. (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16, UPC 57896709167
Distribution pattern: Nationwide in the USA
Recall initiation date: May 7, 2018
Initial firm notification: Letter
Center classification date: Jun 8, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0853-2018, published Jun 20, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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