The Recall Registry
Recall data checked 7 hours ago

Home Prescription medicine Safecor Health, LLC — Simethicone 20 mg per 0.3…

Food & drug recall · FDAFebruary 17, 2025Serious

Safecor Health, LLC — Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375.

Do not stop taking this without speaking to your pharmacist or doctor.

What’s wrong

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

The Recall Registry rates this seriousFDA Class II: temporary or medically reversible health harm.

What to do

Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.

Who to contact: Recalling firm: Safecor Health, LLC

The product

Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375.

Details

Units affected
10992 Oral Syringes
Recall date
February 17, 2025
Brand
Safecor Health, LLC
Model, lot or SKU numbers
Lot #s: 24201295, Exp 02/05/202524210364, Exp 02/20/202524231720, Exp 02/27/202524500770, Exp 06/26/202524471182, Exp 06/20/202525031031, Exp 07/22/2025.
Where it was distributed

Nationwide in the USA

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: Safecor Health, LLC — Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375.

Read it on FDA

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Prescription medicine

Other prescription medicine recalls