The Recall Desk
SevereFDA (Drugs)·D-0181-2021·Announced 2021-01-06

Cipla Recalls Esomeprazole Magnesium Packets Due to Cross-Contamination

Cipla is recalling 284,610 packets of Esomeprazole Magnesium delayed-release oral suspension because the excipient Crospovidone is contaminated with theophylline.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, indicating a reasonable probability of temporary or medically reversible adverse health consequences.

Plain-English summary

Cipla USA, Inc. is recalling 284,610 packets of Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg. The product is a prescription-only medication manufactured by Cipla Ltd. in India and distributed nationwide in the United States. The specific lots affected are KA00411, KA00412, and KA00460, all with an expiration date of 11/2021.

The recall was initiated due to cross-contamination with other products. Specifically, the excipient Crospovidone, NF used in the formulation is contaminated with theophylline. This contamination poses a potential risk to patients, particularly those with specific medical conditions or sensitivities to theophylline.

Patients and healthcare providers should discontinue use of the affected lots and return them to the pharmacy or contact Cipla for a replacement or refund. Consumers should check their medication packaging for the lot numbers and expiration dates listed above to determine if their product is affected.

The recalled product

Product
ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
Brand
ESOMEPRAZOLE MAGNESIUM
Manufacturer
CIPLA
Category
Drug — Prescription Drug
Hazard
Affected units
284,610

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 (4)

  • Lot #: KA00411
  • KA00412
  • KA00460
  • 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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