Teva Recalls Olmesartan Medoxomil and Hydrochlorothiazide Tablets for Dissolution Failure
Teva Pharmaceuticals USA is recalling specific lots of Olmesartan Medoxomil and Hydrochlorothiazide Tablets because they failed to meet dissolution specifications.
What this means for you
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 is reasonably likely to cause temporary or medically reversible health consequences. The hazard is a quality control failure (dissolution) rather than a direct safety hazard like contamination or mislabeling of a dangerous substance, and no injuries or illnesses are reported in the source text.
Plain-English summary
Teva Pharmaceuticals USA is recalling 181,456 bottles of Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg. The affected products are packaged in 30-count bottles (NDC 0093-7617-56) and 90-count bottles (NDC 0093-7617-98). The recall covers specific lots with expiration dates of 02/2019, including lot numbers 49O005, 49O006, 49O007, 49O009, and 49O010.
The recall was initiated because the tablets failed to meet dissolution specifications. Dissolution is a critical quality attribute that ensures the medication breaks down properly in the body to release the active ingredients. When this specification is not met, the medication may not work as intended.
The affected products were distributed nationwide in the U.S.A. Patients and healthcare providers should check their medication bottles for the specific NDC numbers and lot numbers listed above. If the medication matches the recalled lots, it should be returned to the pharmacy or contact Teva Pharmaceuticals USA for further instructions.
The recalled product
- Product
- Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b) 90-count bottle (NDC 0093-7617-98), Rx only, Manufactured In Israel By: Teva Pharmaceutical, IND. LTD., Jerusalem, 9777402, Israel, Manufactured For: Teva Phar
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Antihypertensive
- Affected units
- 181,456
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) 49O005
- 49O006
- 49O007
- 49O010
- Exp 02/2019
- b) 49O005
- 49O009
Distribution
Distributed nationwide across the United States.
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