Zydus Erythromycin Tablets Recall Due to Impurity
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Zydus Pharmaceuticals (USA) Inc. is recalling Erythromycin Tablets, USP, 500 mg due to CGMP deviations involving N-Nitroso-Desmethyl-Erythromycin above acceptable limits.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 10, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Zydus Pharmaceuticals (USA) Inc. initiated a voluntary recall of Erythromycin Tablets due to CGMP deviations and the presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit.
Which Products Are Affected
Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only (NDC 70710-1048-3). Affected lots are M411147 (Expires: 08/2026), M502100 and M502099 (Expires: 01/2027). A total of 10,992 bottles are involved in the nationwide U.S. distribution.
What You Should Do
Consumers should contact their healthcare provider regarding use of the affected product.
Why This Matters
The recall affects over 10,000 bottles of a prescription antibiotic distributed nationwide.
Source
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (836 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.