Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Apr 22, 2015 (11 years ago)

Azithromycin Tablets

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: Firm did not adequately investigate customer complaints.

Cause type: cGMP deviation

Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.

What was recalled

Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 64679-964-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Affected NDCs 64679-0964-01 64679-0964-05

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Drug: Azithromycin Category: Antibiotic

Recalling firm
Wockhardt Usa Inc.
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1263-2015 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Azithromycin recalls

See all
Class II · Moderate risk

Azithromycin tablets

CGMP Deviations: Firm did not adequately investigate customer complaints.

Terminated cGMP deviation American Health Packaging NDC 68084-278-11 D-1223-2015
Class II · Moderate risk

Azithromycin tablets

CGMP Deviations: Firm did not adequately investigate customer complaints.

Terminated cGMP deviation American Health Packaging NDC 68084-464-11 D-1222-2015
Class II · Moderate risk

Azithromycin tablets

CGMP Deviations: Firm did not adequately investigate customer complaints.

Terminated cGMP deviation American Health Packaging NDC 68084-279-11 D-1221-2015

Other recalls by Wockhardt Usa Inc.

All 2015 recalls
Class III · Low risk

Enalapril Maleate tablets

Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.

Terminated Impurity / degradation Wockhardt Usa Inc. D-0051-2018
Class II · Moderate risk

Lisinopril Tablets USP

CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.

Terminated cGMP deviation Wockhardt Usa Inc. NDC 64679-941-06 D-1347-2015