Dr. Reddy's Recalls Lansoprazole Capsules Due to Microbial Contamination
Dr. Reddy's is recalling multiple brands of Lansoprazole Delayed Release Capsules due to out-of-specification microbial counts.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that might cause temporary or medically reversible health consequences. The source text does not report any illnesses or injuries, and the hazard is microbial contamination in a non-sterile product, fitting the criteria for a moderate severity score.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 58,656 bottles of Lansoprazole Delayed Release Capsules, USP 15 mg. The affected products are distributed under various brand names, including Walgreens, Family Wellness, CVS Pharmacy, and Equate. The recall is nationwide.
The recall was initiated because out-of-specification results for microbial count were observed at the initial stability interval for the non-sterile products. The affected lot numbers are 79305114A through 79305114F, with an expiration date of 05/2015.
Consumers should stop using the recalled products and return them to the place of purchase for a refund or follow the instructions provided by the recalling firm.
The recalled product
- Product
- a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Dist by Walgreen Company, 200 Wilmot RD Deerfield IL 60015 b) Family Wellness Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Distributed…
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Antacid / Acid Reducer
- Hazard
- Affected units
- 58,656
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 (7)
- Lot #: a) 79305114A
- b) 79305114B
- c) 79305114C
- d) 79305114D
- e) 79305114E
- f) 79305114F
- Exp 05/2015
Distribution
Distributed nationwide across the United States.
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