FDA Drug recall D-0544-2026
Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed…
- FDA Drug
- Class II
- ongoing
- Published 2026-05-27
On 2026-05-27 the FDA classified a Class II recall of Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed… by Zydus Pharmaceuticals Usa, citing CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0544-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-29 |
| Published | 2026-05-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
Product
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).
Reason
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Identifiers
| ndc | 70710-1047-3 |
|---|---|
| ndc | 70710-1047-1 |
| ndc | 70710-1047-5 |
| ndc | 70710-1048-3 |
| ndc | 70710-1048-1 |
| ndc | 70710-1048-5 |
| code_info | Lots: a) M411146, Expires: 08/2026; M502098, M502097, Expires: 01/2027; b) M411145, Expires: 08/2026. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Other recalls by Zydus Pharmaceuticals Usa
- Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial, 1 Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara - 39151…
FDA Drug · Class II · 2026-10-21 · Zydus Pharmaceuticals Usa - Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, D…
FDA Drug · Class II · 2026-08-12 · Zydus Pharmaceuticals Usa - Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed…
FDA Drug · Class II · 2026-05-27 · Zydus Pharmaceuticals Usa - Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt
FDA Drug · Class II · 2026-03-18 · Zydus Pharmaceuticals Usa - Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt
FDA Drug · Class II · 2026-01-28 · Zydus Pharmaceuticals Usa
All Zydus Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0544-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.