FDA-Drug2026-05-27Class IICHEMICAL
Zydus Pharmaceuticals erythromycin tablets recalled for elevated nitrosamine impurity
What this means
Zydus Pharmaceuticals is recalling erythromycin tablets (250 mg) due to the presence of N-Nitroso-Desmethyl-Erythromycin, a nitrosamine impurity, at levels above the FDA's acceptable intake limit. The affected bottles were distributed nationwide. This impurity can potentially increase cancer risk with long-term exposure.
- Check if you have erythromycin from Zydus Pharmaceuticals with one of the recalled lot numbers (M411146, M502098, M502097, or M411145).
- Contact your pharmacist or doctor before stopping your medication.
- Do not throw away your medication; your pharmacist or doctor will advise you on safe disposal or replacement options.
The agency's original wording
Hazard
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide within the U.S
Affected count
23,880 bottles
Manufactured in
73 Route 31 N, Pennington, NJ, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0544-2026Want us to check the next one for you?
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