RecallRadar

FDA Drug recall D-0869-2023

Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83

On 2023-06-14 the FDA classified a Class II recall of Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83 by Sun Pharmaceutical Industries, citing CGMP Deviations.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0869-2023
ClassificationClass II
Statusterminated
Initiated2023-05-03
Published2023-06-14
Last updated2026-09-13 11:52 UTC
CompanySun Pharmaceutical Industries
DistributionUS

Product

Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.

Reason

CGMP Deviations

Identifiers

ndc62756-459-83
ndc62756-459-64
ndc62756-460-83
ndc62756-460-64
code_infoLot #: DND1515A, Exp 08/24

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-0869-2023%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.