Recall
FDAHealthApril 29, 2026

Zydus Pharmaceuticals (USA) Inc — Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
April 29, 2026

Nationwide within the U.S

What's affected?

Product
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).
Lot code
a)

Additional details

Lots: a) M411146, Expires: 08/2026; M502098, M502097, Expires: 01/2027; b) M411145, Expires: 08/2026.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 23,880 bottles.

View original FDA notice →

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