FDA DrugsClass II
Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured ...
Published: May 27, 2026Recall ID: D-0545-2026Category: drugsCountry: US
Reason for Recall / Hazard
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Product Description & Identification
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).
Additional Source Details
| Field | Value |
|---|---|
| City | Pennington |
| State | NJ |
| Openfda › Nui › 1 | N0000009982 |
| Openfda › Nui › 2 | N0000175877 |
| Openfda › Nui › 3 | N0000175935 |
| Openfda › Nui › 4 | M0028311 |
| Openfda › Unii | 63937KV33D |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 197650 |
| Openfda › Rxcui › 2 | 598006 |
| Openfda › Spl id | 98d365a7-fc2c-4602-aef6-a604c82252c7 |
| Openfda › Brand name | ERYTHROMYCIN |
| Openfda › Spl set id | 0277341c-8513-4317-9334-c242f97630c1 |
| Openfda › Package ndc › 1 | 70710-1047-3 |
| Openfda › Package ndc › 2 | 70710-1047-1 |
| Openfda › Package ndc › 3 | 70710-1047-5 |
| Openfda › Package ndc › 4 | 70710-1048-3 |
| Openfda › Package ndc › 5 | 70710-1048-1 |
| Openfda › Package ndc › 6 | 70710-1048-5 |
| Openfda › Product ndc › 1 | 70710-1047 |
| Openfda › Product ndc › 2 | 70710-1048 |
| Openfda › Generic name | ERYTHROMYCIN |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class cs | Macrolides [CS] |
| Openfda › Pharm class pe | Decreased Sebaceous Gland Activity [PE] |
| Openfda › Substance name | ERYTHROMYCIN |
| Openfda › Pharm class epc › 1 | Macrolide [EPC] |
| Openfda › Pharm class epc › 2 | Macrolide Antimicrobial [EPC] |
| Openfda › Manufacturer name | Zydus Pharmaceuticals USA Inc. |
| Openfda › Application number | ANDA212693 |
| Openfda › Is original packager | true |
| Event id | 98870 |
| Address 1 | 73 Route 31 N |
| Code info | Lots: a) M411147, Expires: 08/2026; M502100, M502099, Expires: 01/2027. |
| Postal code | 08534-3601 |
| Report date | 20260527 |
| Product type | Drugs |
| Product quantity | 10,992 bottles |
| Reason for recall | CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260429 |
| Initial firm notification | Letter |
| Center classification date | 20260520 |
Overview
- Recalling FirmZydus Pharmaceuticals (USA) Inc
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the U.S