FDAFDA · Food and drugs·Recall number D-0544-2026
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).
Published May 27, 2026 · Recall initiated: April 29, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ERYTHROMYCIN
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Distributor
- Nationwide within the U.S
- Lot
- Lots: a) M411146, Expires: 08/2026; M502098, M502097, Expires: 01/2027; b) M411145, Expires: 08/2026.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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