Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Clarithromycin recalled?

Not under an active recall. Clarithromycin was recalled 5 times in the past — all now closed. Most recent: Jun 1, 2015.

Most common reason: cGMP deviation (3 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Clarithromycin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Clarithromycin recalls on record

none so far in 2026; 5 on record, newest first
Class II · Moderate risk

Clarithromycin tablets

CGMP Deviations: Firm did not adequately investigate customer complaints.

Terminated cGMP deviation American Health Packaging NDC 68084-437-11 D-1224-2015
Class II · Moderate risk

Clarithromycin Tablets

cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure

Terminated cGMP deviation Blenheim Pharmacal, Inc. NDC 10544-522-20 D-1110-2015
Class II · Moderate risk

Clarithromycin Tablets

CGMP Deviations: Firm did not adequately investigate customer complaints.

Terminated cGMP deviation Wockhardt Usa Inc. D-1249-2015
Class II · Moderate risk

Clarithromycin active pharmaceutical ingredient packaged in…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-592-2015
Class II · Moderate risk

triple therapy

Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.

Terminated Impurity / degradation Teva Pharmaceuticals USA NDC 0093-8055-78 D-1499-2014