RecallRadar

FDA Drug recall D-268-2013

Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only

On 2013-05-01 the FDA classified a Class II recall of Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only by Sandoz, citing presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-268-2013
ClassificationClass II
Statusterminated
Initiated2013-04-18
Published2013-05-01
Last updated2026-09-13 11:51 UTC
CompanySandoz
DistributionUS

Product

Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles.

Reason

Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.

Identifiers

ndc0781-2020-31
ndc0781-2020-76
ndc0781-2020-01
ndc0781-2020-05
ndc0781-2613-31
ndc0781-2613-76
ndc0781-2613-01
ndc0781-2613-05
ndc0781-5060-20
ndc0781-5060-01
ndc0781-5061-20
ndc0781-5061-01
ndc0781-6039-58
ndc0781-6039-46
ndc0781-6039-55
ndc0781-6156-52
ndc0781-6156-57
ndc0781-6156-46
ndc0781-6041-58
ndc0781-6041-46
ndc0781-6041-55
ndc0781-6157-52
ndc0781-6157-57
ndc0781-6157-46
code_infoCK2003, CK2004 exp. 04/15, CR4110, CR4111, CS2983, CS2986, CS2988, CS2989, CS2990, CS2991, CS2992, CS2993, CS2994 exp. 07/15, CK3616, CK3617 exp. 04/15

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-268-2013%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.