Agency classClass IIOur severity:High FDA (Drugs)·D-268-2013·Announced 2013-05-01

Sandoz Recalls Amoxicillin Capsules Due to Stainless Steel Contamination

Sandoz is recalling specific lots of Amoxicillin Capsules USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.

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 physical foreign substance (stainless steel wire mesh) in an oral medication, which poses a risk of injury (such as choking or internal damage) even though no specific injuries are reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Sandoz Incorporated is recalling certain lots of Amoxicillin Capsules, USP 500 mg. The recall is being conducted because the product may be contaminated with fragments of stainless steel wire mesh.

The affected product is Amoxicillin Capsules USP 500 mg, manufactured in Austria by Sandoz GmbH for Sandoz Inc. The recall includes 30-count and 500-count bottles (NDC 0781-2613-31 and NDC 0781-2613-05). The specific lot codes involved are CK2003, CK2004, CR4110, CR4111, CS2983, CS2986, CS2988, CS2989, CS2990, CS2991, CS2992, CS2993, CS2994, CK3616, and CK3617.

Consumers should check their medication for these specific lot codes and expiration dates (04/15 or 07/15). If the product matches the recalled lots, consumers should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or disposal.

The recalled product

Product: AMOXICILLIN (AMOXICILLIN)
Brand: AMOXICILLIN
Manufacturer: Sandoz Incorporated
Category: Drug — Antibiotic
Hazard: foreign-object
choking
internal-injury

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 (15)

CK2003
CK2004 exp. 04/15
CR4110
CR4111
CS2983
CS2986
CS2988
CS2989
CS2990
CS2991
CS2992
CS2993
CS2994 exp. 07/15
CK3616
CK3617 exp. 04/15

UPCs (8)

0307816156526
0307812020012
0307816041587
0307815060015
0307815061012
0307816157523
0307816039584
0307812613016

Distribution

Distributed nationwide across the United States.

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