Erythromycin Tablets, 250 mg recall — Zydus Pharmaceuticals (usa) Inc (Class II)
Zydus Pharmaceuticals (usa) Inc is recorded by the U.S. Food and Drug Administration (FDA) as recalling Erythromycin Tablets, 250 mg — a Class II recall, initiated 2026-04-29 and posted to the FDA enforcement report on 2026-05-27, under recall number D-0544-2026. Status Ongoing, with no termination date on the record. The reason the FDA record carries is, verbatim: “CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit”. From the product description, the form is tablets, the strength given is 250 mg, the package is described as 30 tablets and 30 count bottles, and 1 more and it is marked Rx only. 2 National Drug Code numbers are printed in the record: 70710-1047-3 and 70710-1047-1. Distribution is recorded as “Nationwide within the U.S” — Nationwide (US), with the recalling firm on record in NJ, United States. The FDA files it under event ID 98870 together with 1 other recall number, all listed and linked below. Within that event this is the strength 250 mg, package 30 tablets · 30 count bottles · 100 count bottles and ndc 70710-1047-3 · 70710-1047-1 configuration; the sibling records differ on strength, package and ndc and match on everything else the source states. Values are reproduced from the linked openFDA report; regulatory information, not medical advice.
Regulatory snapshot
| Recall number | D-0544-2026 |
|---|---|
| FDA event ID | 98870 (2 recall numbers) |
| Classification | Class II (intermediate regulatory tier) |
| Status | Ongoing |
| Recalling firm | Zydus Pharmaceuticals (usa) Inc |
| Recall initiated | 2026-04-29 |
| Reported by FDA | 2026-05-27 |
| Report lag | 28 days from initiation to report |
| Distribution | Nationwide within the U.S — Nationwide (US) |
| Firm location on record | NJ, United States |
| Product description (source) | 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 reported by FDA
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
11 words from the enforcement report field reason_for_recall, reproduced without edit — the firm's own wording, not an assessment.
Product identifiers in this record
10 identifying values matched by exact pattern in the 39-word product description above; each is a literal substring of it.
| Product named | Erythromycin Tablets |
|---|---|
| Form | Tablets |
| Strength | 250 mg |
| Package | 30 tablets · 30 count bottles · 100 count bottles |
| NDC | 70710-1047-3 · 70710-1047-1 |
| Marketing category | Rx only |
| Manufactured by | Zydus Lifesciences Ltd., Ahmedabad |
| Distributed by | Zydus Pharmaceuticals (USA) Inc., Pennington |
Which configuration this record is
2 recall numbers share event 98870. They differ on strength, package and ndc and agree on everything else the source states, so those are the values to check a package against.
| Attribute | This record (D-0544-2026) | D-0545-2026 |
|---|---|---|
| Strength | 250 mg | 500 mg |
| Package | 30 tablets · 30 count bottles · 100 count bottles | 30 tablets |
| NDC | 70710-1047-3 · 70710-1047-1 | 70710-1048-3 |
Shared across all 2 records under this event: form Tablets; product named Erythromycin Tablets; fda tier Class II; recalling firm Zydus Pharmaceuticals (usa) Inc; the same reason text; initiated 2026-04-29; reported 2026-05-27.
Event context: 2 recall numbers under event 98870
One enforcement action, 2 recall numbers: the FDA filed 1 further configuration of this action under event 98870. Each keeps its own recall number and dates.
| Recall record | Recall number | FDA tier | Strength / form | NDC | Reported |
|---|---|---|---|---|---|
| Erythromycin Tablets, 500 mg | D-0545-2026 | Class II | 500 mg · Tablets | 70710-1048-3 | 2026-05-27 |
Other indexed recalls from Zydus Pharmaceuticals (usa) Inc
3 indexed records name Zydus Pharmaceuticals (usa) Inc as the recalling firm, across 2 FDA events, reported 2026-05-27 to 2026-08-12. A coverage-limited activity count over the ingested window, not a quality rating.
| Recall record | Recall number | FDA tier | Strength / form | Reported |
|---|---|---|---|---|
| Mirabegron Extended-Release Tablets, 25 mg | D-0745-2026 | Class II | 25 mg · Extended-Release Tablets | 2026-08-12 |
Reported in the same month (2026-05)
48 enforcement reports carry a report date in 2026-05; these 8 are the Class II ones nearest this record.
| Recall record | Recall number | Recalling firm | FDA tier | Reported |
|---|---|---|---|---|
| Atomoxetine Capsules HCL, 10 mg | D-0538-2026 | Safecor Health, LLC | Class II | 2026-05-27 |
| Liraglutide Injection, 18 mg/3 mL | D-0541-2026 | Lupin Pharmaceuticals Inc. | Class II | 2026-05-27 |
| Gas-X, 125 mg | D-0542-2026 | Haleon US Holdings LLC | Class II | 2026-05-27 |
| Estradiol Gel, 0.1% | D-0543-2026 | Ani Pharmaceuticals, Inc. | Class II | 2026-05-27 |
| cimzia (certolizumab pegol) | D-0546-2026 | Ucb Biosciences Inc. | Class II | 2026-05-27 |
| fentaNYL Citrate, 2,2500 mcg/50mL | D-0548-2026 | Integradose Compounding Services LLC | Class II | 2026-05-27 |
| Vitamin B-Complex, 799 mcg/5mL | D-0549-2026 | Safecor Health, LLC | Class II | 2026-05-27 |
| Oasis Tears PF, 10mL | D-0525-2026 | Oasis Medical, Inc. | Class II | 2026-05-20 |
Nearest Class II recalls by date
213 of 250 indexed records share the Class II tier; the 6 nearest to 2026-05-27 by report date are listed here.
| Recall record | Recall number | Recalling firm | Strength / form | Reported |
|---|---|---|---|---|
| Buprenorphine Hydrochloride, 0.3mg/mL | D-0527-2026 | Endo Usa, Inc. | 0.3mg/mL · Injection | 2026-05-20 |
| Ascend Laboratories, 25 mg | D-0547-2026 | Ascend Laboratories, LLC | 25 mg · Extended-Release Tablets | 2026-05-20 |
| DELFLEX, 1.5% | D-0512-2026 | Fresenius Medical Care Holdings, Inc. | 1.5% · Solution | 2026-05-13 |
| DELFLEX, 2.5% | D-0513-2026 | Fresenius Medical Care Holdings, Inc. | 2.5% · Solution | 2026-05-13 |
| Duloxetine Delayed-Release Capsules, 30 mg | D-0514-2026 | Ajanta Pharma Ltd. | 30 mg · Delayed-Release Capsules | 2026-05-13 |
| Duloxetine Delayed-Release Capsules, 60 mg | D-0515-2026 | Ajanta Pharma Ltd. | 60 mg · Delayed-Release Capsules | 2026-05-13 |
Reading this record
Class II is the FDA's own severity tier for the recall action — 213 of the 250 indexed records carry it — and it describes the agency's assessment of the action, not a risk statement about any individual. A search on event 98870 returns all 2 of these recall numbers; a search on D-0544-2026 returns only this configuration. Match a package against 70710-1047-3 and 70710-1047-1 at the FDA source to confirm it is covered.
Namespace context: the Class II index (213 records) and the recall hub (250 records, 118 FDA events); Zydus Pharmaceuticals (usa) Inc (3 indexed records) aggregates this firm across datasets.
Coverage and limits of this record
This page reflects the openFDA enforcement report for D-0544-2026 as ingested on 2026-08-22, which can lag the live FDA record and omits detail held only in primary documents. It offers no clinical assessment, no advice about whether to use any product, and no substitute. For any health question consult a qualified healthcare professional.
Source & provenance
- Official source
- https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0544-2026%22
- Source dataset
- openFDA Drug Enforcement API
- Publication date
- 2026-05-27
- Ingested
- 2026-08-22
- Record hash
75bb493e75777d1d
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.