Lupin Recalls Lisinopril and Hydrochlorothiazide Tablets Due to CGMP Deviations
Lupin Pharmaceuticals is recalling specific lots of Lisinopril and Hydrochlorothiazide tablets because they were manufactured using active ingredients that failed 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 III, which by definition is unlikely to cause adverse health consequences. The issue involves CGMP deviations regarding ingredient specifications, which is a quality control matter without reported illness or injury.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling 59,520 bottles of Lisinopril and Hydrochlorothiazide tablets, USP 20mg/12.5mg. The affected products are packaged in 100-count and 5,000-count bottles and are available by prescription only. The specific lots involved are H303459 and H303460, with an expiration date of 09/2016.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the finished products were manufactured using active pharmaceutical ingredients whose intermediates failed to meet required specifications. This indicates a quality control issue during the manufacturing process rather than a confirmed contamination or labeling error.
The affected products were distributed nationwide and in Puerto Rico. Patients who have been prescribed this medication should consult their healthcare provider or pharmacist for guidance on whether to continue using the medication or obtain a replacement. Consumers should check their medication bottles for the specific lot numbers and expiration dates listed above.
The recalled product
- Product
- LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE)
- Brand
- LISINOPRIL AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 59,520
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 (3)
- Lot #: a) H303459
- b) H303460
- Exp 09/2016
UPCs (3)
- 0368180519010
- 0368180518013
- 0368180520016
Distribution
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