RecallRadar

FDA Drug recall D-0085-2023

Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bo…

On 2022-12-28 the FDA classified a Class II recall of Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bo… by Sun Pharmaceutical Industries, citing presence of foreign substance.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0085-2023
ClassificationClass II
Statusterminated
Initiated2022-12-01
Published2022-12-28
Last updated2026-09-13 11:52 UTC
CompanySun Pharmaceutical Industries
DistributionUS

Product

Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bottles (NDC 62756-185-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India.

Reason

Presence of foreign substance

Identifiers

ndc62756-183-83
ndc62756-183-88
ndc62756-183-08
ndc62756-183-13
ndc62756-183-18
ndc62756-184-83
ndc62756-184-88
ndc62756-184-08
ndc62756-184-13
ndc62756-184-18
ndc62756-185-83
ndc62756-185-88
ndc62756-185-08
ndc62756-185-13
ndc62756-185-18
code_infoa) Lot HAC1474A, Expires 03/2023 b) Lot HAC1503A, Expires 03/2023 c) Lot HAC1474B, Expires 03/2023

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0085-2023%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.