FreshRecalls

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FDAClass II · Drug · Recalled May 27, 2026

Erythromycin Tablets recall — Zydus Pharmaceuticals (USA) Inc

Hazard: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
D-0544-2026
Brand
Zydus Pharmaceuticals (USA)
Classification
Class II
Units affected
23,880 bottles
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles (NDC 70710-1047-3); b) 100 count bottles (NDC 70710-1047-1).

Affected products

Companies & origin

Recalling firm location
Pennington, NJ, United States
Firm address
73 Route 31 N, 08534-3601

Identifying details (verbatim from the notice)

Product codes / lots
Lots: a) M411146, Expires: 08/2026; M502098, M502097, Expires: 01/2027; b) M411145, Expires: 08/2026.
Distribution
Nationwide within the U.S
Firm notified the public via
Letter
FDA event ID
98870
Recall initiated
April 29, 2026
FDA classified
May 20, 2026
FDA report date
May 27, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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