Drug FDA Class II Ongoing cGMP deviation
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).
Zydus Pharmaceuticals (USA) Inc Published May 27, 2026
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 60/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Zydus Pharmaceuticals (USA) Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Hazards
N-Nitroso-Desmethyl-Erythromycin · primary
Affected products (1)
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).
ERYTHROMYCIN · 10,992 bottles
NDC: 70710-1047, 70710-1048, 70710-1047-3, 70710-1047-1, 70710-1047-5, 70710-1048-3, 70710-1048-1, 70710-1048-5
Code info: Lots: a) M411147, Expires: 08/2026; M502100, M502099, Expires: 01/2027.
Affected areas
Nationwide
Timeline
- InitiatedApr 29, 2026
- PublishedMay 27, 2026
- Recall number
- D-0545-2026
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.