FDA Drug recall D-0639-2022

Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc

FDA Drug
Class II
terminated
Published 2022-03-09

On 2022-03-09 the FDA classified a Class II recall of Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc by Macleods Pharma Usa, citing cGmp Deviations.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0639-2022
Classification	Class II
Status	terminated
Initiated	2022-02-16
Published	2022-03-09
Last updated	2026-09-13 11:52 UTC
Company	Macleods Pharma Usa
Distribution	US

Product

Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, India, NDC 33342-070-07.

Reason

cGmp Deviations

Identifiers

ndc	33342-067-07
ndc	33342-067-44
ndc	33342-067-12
ndc	33342-067-11
ndc	33342-068-07
ndc	33342-068-44
ndc	33342-068-12
ndc	33342-068-11
ndc	33342-069-07
ndc	33342-069-44
ndc	33342-069-12
ndc	33342-069-11
ndc	33342-070-07
ndc	33342-070-15
ndc	33342-070-12
ndc	33342-070-44
ndc	33342-070-11
ndc	33342-071-07
ndc	33342-071-15
ndc	33342-071-12
ndc	33342-071-44
ndc	33342-071-11
ndc	33342-072-07
ndc	33342-072-15
ndc	33342-072-12
ndc	33342-072-44
ndc	33342-072-11
code_info	Lot #: BOB42029A, BOB4202B, Exp. Date 09/2022

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-0639-2022%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.