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Class II · ModerateActive recall

Erythromycin

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLots: a) M411146, Expires: 08/2026; M502098, M502097, Expires: 01/2027; b) M411145, Expires: 08/2026.
Where it was soldNationwide within the U.S
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byZydus 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) foreign manufacturer
Brand nameERYTHROMYCIN
Generic nameERYTHROMYCIN
Active ingredient(s)ERYTHROMYCIN
Distributed by / forZydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles (NDC 70710-1047-3); b) 100 count bottles (NDC 70710-1047-1)
NDC70710-1047-3
Show the full FDA record
Full product labelErythromycin 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).
Recalling firmZydus Pharmaceuticals (USA) Inc
DistributionNationwide within the U.S
Quantity23,880 bottles
Recall initiated2026-04-29
Report date2026-05-27
Recall completed—
Recall numberD-0544-2026
ClassificationClass II
FDA statusOngoing
Origin on filePennington NJ United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.