The Recall Desk
HighFDA (Drugs)·D-0183-2021·Announced 2021-01-06

Cipla Recalls Esomeprazole Magnesium Due to Theophylline Contamination

Cipla is recalling specific lots of Esomeprazole Magnesium delayed-release oral suspension because the excipient Crospovidone is contaminated with theophylline.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves cross-contamination with theophylline, a medication that can cause adverse health consequences, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Cipla USA, Inc. is recalling 6,491 packets of Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg. The affected product is packaged in unit dose packets and is prescription-only. The specific lots involved are KA00415 and KA00416, both with an expiration date of 11/2021. The product was distributed nationwide in the United States.

The recall was initiated due to cross-contamination with other products. Specifically, the excipient Crospovidone, NF used in the formulation is contaminated with theophylline. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and patients should discontinue use of the affected lots. Consumers should check their medication packaging for the lot numbers KA00415 or KA00416 and the expiration date 11/2021. If the product matches these details, it should be returned to the pharmacy or disposed of according to local regulations.

The recalled product

Product
ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
Brand
ESOMEPRAZOLE MAGNESIUM
Manufacturer
CIPLA
Category
Drug — Prescription Drug
Hazard
Affected units
6,491

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot #: KA00415
  • KA00416
  • Exp 11/2021

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by CIPLA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same brand · ESOMEPRAZOLE MAGNESIUM

Same manufacturer · CIPLA

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Same hazard · cross contamination

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