FDA recall, , Moderate risk
Zydus Erythromycin Tablets
Zydus Pharmaceuticals is recalling its Zydus Erythromycin Tablets, USP because of CGMP deviations and presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit.
Summary by Recall Canary from the FDA notice
What happened
Zydus Pharmaceuticals (USA) Inc. of Pennington, New Jersey recalled Erythromycin Tablets, USP in 500 mg and 250 mg strengths because of CGMP deviations and the presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit. The recall began April 29, 2026 and was added to the FDA's Enforcement Report on May 20, 2026. The tablets were distributed nationwide within the U.S.
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What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Affected if its lot code and NDC are listed under that product.
An NDC (National Drug Code) is usually printed on the drug's label.
Erythromycin Tablets, USP
- Strength
- 500 mg
- NDC
- 70710-1048-3
- Lot code
- M411147
- M502100
- M502099
- Strength
- 250 mg
- NDC
- 70710-1047-3
- 70710-1047-1
- Lot code
- M411146
- M502098
- M502097
- M411145
Recall details
- Company began the recall
- Sold in
Nationwide within the U.S
- Company
- Zydus Pharmaceuticals (USA) IncPennington, New Jersey
- Hazard
- Drug impurity
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98870
- Recall numbers
- D-0544-2026 to D-0545-2026
All recalls from Zydus Pharmaceuticals (USA) Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
