Key facts
| Recalling firm | Zydus Pharmaceuticals (USA) Inc |
|---|---|
| Manufacturer | Zydus Pharmaceuticals USA Inc. |
| Brand name | ERYTHROMYCIN |
| Product description | 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). |
| Classification | Class II |
| Recall number | D-0544-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| Reason for recall | CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit |
What this classification means
FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Zydus Pharmaceuticals (USA) Inc and the affected product is described in FDA's record as: 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).. FDA's stated reason for the recall is: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit. The recall is tracked under FDA recall number D-0544-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.
What consumers should do
Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- 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). -- and the recall number D-0544-2026. If it matches, stop using or distributing it and contact Zydus Pharmaceuticals (USA) Inc or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.
Zydus Pharmaceuticals (USA) Inc’s FDA history
Argus HQ has recorded 4 total FDA actions tied to Zydus Pharmaceuticals (USA) Inc: 1 warning letter, 2 recalls, 1 approval record, and 0 Form 483 inspection citations.
Frequently asked questions
- How serious is this recall?
- FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
- What should someone who has this product do?
- Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (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).) and recall number D-0544-2026, then follow.
- Has Zydus Pharmaceuticals (USA) Inc had other FDA recalls or enforcement actions?
- Yes. Argus HQ has recorded 4 total FDA actions tied to Zydus Pharmaceuticals (USA) Inc, including 2 recalls and 1 warning letter.
- What is the FDA recall number for this event?
- FDA recall number D-0544-2026.
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Related enforcement actions
Full FDA history for Zydus Pharmaceuticals (USA) IncCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Recall Database: Class II Recall: ERYTHROMYCIN by Zydus Pharmaceuticals (USA) Inc. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-zydus-pharmaceuticals-usa-inc-d-0544-2026
"FDA Recall Database: Class II Recall: ERYTHROMYCIN by Zydus Pharmaceuticals (USA) Inc." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-zydus-pharmaceuticals-usa-inc-d-0544-2026.
Argus HQ Research. "FDA Recall Database: Class II Recall: ERYTHROMYCIN by Zydus Pharmaceuticals (USA) Inc." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-zydus-pharmaceuticals-usa-inc-d-0544-2026.
@misc{argushq_argushq_ai_recall_fda_recall_zydus_pharmaceuticals_usa_inc_d_0544_2026_2026,
title = {FDA Recall Database: Class II Recall: ERYTHROMYCIN by Zydus Pharmaceuticals (USA) Inc},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/recall/fda-recall-zydus-pharmaceuticals-usa-inc-d-0544-2026},
note = {Accessed: July 13, 2026}
}Source: FDA.gov — Recalls ↗