Zydus Erythromycin Tablets Recall Issued by FDA

Source: FDA · United States

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Zydus Pharmaceuticals (USA) Inc. is recalling 23,880 bottles of Erythromycin Tablets, USP, 250 mg due to CGMP deviations and an impurity exceeding 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Zydus Pharmaceuticals (USA) Inc. initiated a voluntary recall of Erythromycin Tablets, USP, 250 mg due to CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit. The recall is classified as Class II.

Which Products Are Affected

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)

Affected lots:

  • a) M411146 (Expires: 08/2026); M502098, M502097 (Expires: 01/2027)
  • b) M411145 (Expires: 08/2026)

A total of 23,880 bottles were distributed nationwide within the U.S.

What You Should Do

The initial firm notification was by letter. Consumers should contact their healthcare provider regarding the recalled product.

Why This Matters

This ongoing Class II recall affects prescription medication distributed across the United States.

Source

FDA recall number D-0544-2026. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Zydus Pharmaceuticals (USA) Inc. is recalling 23,880 bottles of Erythromycin Tablets, USP, 250 mg due to CGMP deviations and an impurity exceeding acceptable limits.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.