HIGHFDA DRUG

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;...

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

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DRUG
Recall date
April 29, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
April 29, 2026
Hazard Level
HIGH
Brands
ERYTHROMYCIN, Zydus Pharmaceuticals USA Inc.
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
ERYTHROMYCIN, Zydus Pharmaceuticals USA Inc.
Model numbers
Lots: a) M411147, Expires: 08/2026, M502100, M502099, Expires: 01/2027.
UPC codes
70710-1047, 70710-1048, 70710-1047-3, 70710-1047-1, 70710-1047-5, 70710-1048-3, 70710-1048-1, 70710-1048-5
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    April 29, 2026

  2. Reported by FDA DRUG

    May 27, 2026

  3. RecallRadar source check

    June 3, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: Letter

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Full Description

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).. Generic: ERYTHROMYCIN; Brand: ERYTHROMYCIN. Reason: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit. Classification: Class II. Quantity: 10,992 bottles. Distribution: Nationwide within the U.S

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
Lots: a) M411147
Expires: 08/2026
M502100
M502099
Expires: 01/2027.
UPC Codes
70710-1047
70710-1048
70710-1047-3
+5 more
Affected States
ALL
Report Date
May 27, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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