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CLASS II · ModerateFDA

Zydus Pharmaceuticals (USA) Inc recalls Erythromycin Tablets

📅 Apr 29, 2026 · 📍 Nationwide
Recalling company
Zydus Pharmaceuticals (USA) Inc
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).
Reason
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Apr 29, 2026
Reported
May 27, 2026
Distribution
Nationwide within the U.S
Status
Ongoing
Quantity
23,880 bottles
Lot / codes
Lots: a) M411146, Expires: 08/2026; M502098, M502097, Expires: 01/2027; b) M411145, Expires: 08/2026.
Company location
Pennington, NJ
Recall type
Voluntary: Firm initiated
Recall number
D-0544-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0544-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.