Qualitest Recalls Hydrochlorothiazide Capsules Due to Particulate Matter
Vintage Pharmaceuticals is recalling 912 bottles of 12.5 mg Hydrochlorothiazide capsules because of the presence of particulate matter.
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, and the hazard is particulate matter, which is a quality defect without reported serious injuries or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Vintage Pharmaceuticals LLC, doing business as Qualitest Pharmaceuticals, is recalling 912 bottles of Hydrochlorothiazide Capsules, USP, 12.5 mg. The product is distributed in 3000-count bottles and is available by prescription only.
The recall is being conducted due to the presence of particulate matter in the capsules. The affected product is identified by NDC 0603-3855-93 and has expiration dates of 12/16. The specific lot codes involved are T084M14A, T085M14A, and T086M14A.
The product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manufactured for: Qualitest Pharmaceuticals, Inc., Huntsville, AL 35811, NDC: 0603-3855-93.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 912
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)
- T084M14A
- T085M14A
- T086M14A
- Exp 12/16
Distribution
Distributed nationwide across the United States.
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