Dr. Reddy's Recalls Esomeprazole Magnesium Capsules Due to Discoloration
Dr. Reddy's Laboratories is recalling 1,752 bottles of Esomeprazole Magnesium 40 mg capsules because the product contains brown pellets.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a cosmetic defect (discoloration) with no reported injuries or illnesses.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 1,752 bottles of Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg. The recall is due to discoloration, specifically the presence of brown pellets in the product.
The affected product is identified by Lot # C900642 and has an expiration date of 06/2020. The 1,000-count bottles were distributed nationwide within the United States.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
- Brand
- ESOMEPRAZOLE MAGNESIUM
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 1,752
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 (2)
- Lot #: C900642
- Exp. 06/2020
Distribution
Distributed nationwide across the United States.
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