Zydus Pharmaceuticals (usa) Inc: Erythromycin Tablets, Usp, 500 Mg, 30 Tablets Per Bottle
Recall Summary Zydus Pharmaceuticals is recalling Erythromycin Tablets (500 mg, 30-tablet bottles) distributed nationwide because the medication contains higher-than-acceptable levels of N-Nitroso-Desmethyl-Erythromycin, a potential impurity. The affected product was manufactured by Zydus Lifesciences Ltd. in India and distributed across all U.S. states and Washington, D.C.
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Product
- Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3).
- Reason
- CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-29
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide within the U.S
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/336dfa5a-ca8d-4161-bbb5-90f5ac8bad20