Zydus Erythromycin Tablets Recall: N-Nitroso-Desmethyl-Erythromycin Risk
Zydus Pharmaceuticals recalls 500mg erythromycin tablets with N-Nitroso-Desmethyl-Erythromycin above safe limits. Rx-only medication from India distributed in US. Stop using immediately.
Recall notice
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Contact the company
What happened, in plain English
Zydus Pharmaceuticals is recalling 500mg erythromycin tablets that contain a chemical (N-Nitroso-Desmethyl-Erythromycin) above safe levels. This could pose a health risk to people who take these medications as prescribed. Read more at govinfonow.com/recall/31322-zydus-erythromycin-tablets-recall-n-nitroso-desmethyl-erythromycin-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/31322-zydus-erythromycin-tablets-recall-n-nitroso-desmethyl-erythromycin-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0545-2026
Cite this page
“Zydus Erythromycin Tablets Recall: N-Nitroso-Desmethyl-Erythromycin Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31322-zydus-erythromycin-tablets-recall-n-nitroso-desmethyl-erythromycin-risk. Based on FDA recall #D-0545-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0545-2026%22&limit=1).
Why it’s dangerous
The tablets contain N-Nitroso-Desmethyl-Erythromycin at levels above the acceptable intake limit. This chemical is a potential health risk when taken as directed. The exact health effects are not specified in the recall notice.
Who’s affected
People who have been prescribed this prescription-only medication and received the recalled tablets from Zydus Pharmaceuticals (USA) Inc. Those with specific health conditions requiring erythromycin may be at higher risk.
How to tell if you have this one
Check for the product name 'Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle' with NDC 70710-1048-3. Look for lots M411147 (expires 08/2026) or M502100/M502099 (expires 01/2027).
- Brand
Zydus Pharmaceuticals- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide within the U.S- NDC
70710-1047-3, 70710-1047-1, 70710-1047-5, 70710-1048-3, 70710-1048-1, 70710-1048-5
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0544-2026 | 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).; Lots: a) M411146, Expires: 08/2026; M502098, M502097, Expires: 01/2027; b) M411145, Expires: 08/2026. | 23,880 bottles |
| D-0545-2026 | 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).; Lots: a) M411147, Expires: 08/2026; M502100, M502099, Expires: 01/2027. | 10,992 bottles |
What to do — step by step
Stop Using Immediately
Discard the recalled tablets if you have them. Do not take them.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the U.S” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 28 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Other Zydus Pharmaceuticals recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0545-2026 (April 29, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0545-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.