Breckenridge Recalls Omeprazole Capsules Due to Unknown Impurities
Breckenridge Pharmaceutical is recalling 3,146 bottles of Omeprazole Delayed-Release Capsules, 20 mg, due to out-of-specification results for unknown impurities.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard involves unknown impurities detected during stability testing, which fits the criteria for a moderate severity recall involving potential quality issues without confirmed harm.
Plain-English summary
Breckenridge Pharmaceutical, Inc. is recalling 3,146 bottles of Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles. The product is prescription-only and was distributed nationwide. The specific lot number is 191659, with an expiration date of 05/2021.
The recall was initiated because stability testing revealed out-of-specification results for unknown impurities. The product was manufactured by Tow Pharmaceutical Europe, S.L. in Martorelles (Barcelona), Spain, and distributed by Breckenridge Pharmaceutical, Inc. in Berlin, CT.
Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or point of purchase for disposal or replacement.
The recalled product
- Product
- Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10
- Manufacturer
- Breckenridge Pharmaceutical, Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 3,146
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 # 191659
- exp. date 05/2021
Distribution
Distributed nationwide across the United States.
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