FDA Drug recall D-1248-2015

Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches (NDC: 64679-961-08)…

FDA Drug
Class II
terminated
Published 2015-07-29

On 2015-07-29 the FDA classified a Class II recall of Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches (NDC: 64679-961-08)… by Wockhardt Usa, citing CGMP Deviations: Firm did not adequately investigate customer complaints.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-1248-2015
Classification	Class II
Status	terminated
Initiated	2015-04-22
Published	2015-07-29
Last updated	2026-09-13 11:51 UTC
Company	Wockhardt Usa
Distribution	US

Product

Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches (NDC: 64679-961-08), and C) 3 x 6 Tablet Card Cartons (NDC: 64679-961-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Reason

CGMP Deviations: Firm did not adequately investigate customer complaints.

Identifiers

code_info	A) Lot #: LM10712, Expiry: 4/30/2015; Lot #: LM10874, Expiry: 4/30/2015; Lot #: LM11040, Expiry: 5/31/2015; Lot #: LM11… A) Lot #: LM10712, Expiry: 4/30/2015; Lot #: LM10874, Expiry: 4/30/2015; Lot #: LM11040, Expiry: 5/31/2015; Lot #: LM11169, Expiry: 6/30/2015; Lot #: LM11401, Expiry: 6/30/2015; Lot #: LM12132, Expiry: 11/30/2015; Lot #: LN10039, Expiry: 12/31/2015; Lot #: LN10263, Expiry: 12/31/2015; Lot #: LN10276, Expiry: 12/31/2015; Lot #: LN10417, Expiry: 1/31/2016, Lot #: LN11365, Expiry: 8/31/2016. B) Lot #: LN11264, Expiry: 7/31/2015; Lot #: LN11373, Expiry: 8/31/2015; Lot #: LN11375, Expiry: 8/31/2015. C) Lot #: LM10686, Expiry: 4/30/2015; Lot #: LM10757, Expiry: 4/30/2015; Lot #: LM10855, Expiry: 4/30/2015; Lot #: LM10893, Expiry: 5/31/2015; Lot #: LM10945, Expiry: 5/31/2015; Lot #: LM10989, Expiry: 4/30/2015; Lot #: LM11117, Expiry: 6/30/2015; Lot #: LM11168, Expiry: 6/30/2015; Lot #: LM11214, Expiry: 6/30/2015; Lot #: LM11624, Expiry: 9/30/2015; Lot #: LM11797, Expiry: 10/31/2015; Lot #: LM11820, Expiry: 10/31/2015; Lot #: LM11959, Expiry: 10/31/2015; Lot #: LM12000, Expiry: 10/31/2015; L

code_info

A) Lot #: LM10712, Expiry: 4/30/2015; Lot #: LM10874, Expiry: 4/30/2015; Lot #: LM11040, Expiry: 5/31/2015; Lot #: LM11…

A) Lot #: LM10712, Expiry: 4/30/2015; Lot #: LM10874, Expiry: 4/30/2015; Lot #: LM11040, Expiry: 5/31/2015; Lot #: LM11169, Expiry: 6/30/2015; Lot #: LM11401, Expiry: 6/30/2015; Lot #: LM12132, Expiry: 11/30/2015; Lot #: LN10039, Expiry: 12/31/2015; Lot #: LN10263, Expiry: 12/31/2015; Lot #: LN10276, Expiry: 12/31/2015; Lot #: LN10417, Expiry: 1/31/2016, Lot #: LN11365, Expiry: 8/31/2016. B) Lot #: LN11264, Expiry: 7/31/2015; Lot #: LN11373, Expiry: 8/31/2015; Lot #: LN11375, Expiry: 8/31/2015. C) Lot #: LM10686, Expiry: 4/30/2015; Lot #: LM10757, Expiry: 4/30/2015; Lot #: LM10855, Expiry: 4/30/2015; Lot #: LM10893, Expiry: 5/31/2015; Lot #: LM10945, Expiry: 5/31/2015; Lot #: LM10989, Expiry: 4/30/2015; Lot #: LM11117, Expiry: 6/30/2015; Lot #: LM11168, Expiry: 6/30/2015; Lot #: LM11214, Expiry: 6/30/2015; Lot #: LM11624, Expiry: 9/30/2015; Lot #: LM11797, Expiry: 10/31/2015; Lot #: LM11820, Expiry: 10/31/2015; Lot #: LM11959, Expiry: 10/31/2015; Lot #: LM12000, Expiry: 10/31/2015; L

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-1248-2015%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.