Lupin Recalls Lisinopril and Hydrochlorothiazide Tablets Due to Foreign Substance
Lupin Pharmaceuticals is recalling specific bottles of Lisinopril and Hydrochlorothiazide tablets due to the presence of brownish or blackish stains and powder.
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 typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The hazard is a foreign substance (stains/powder) without reported serious injuries or fatalities, fitting the Moderate severity criteria for low-risk contamination or precautionary recalls.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling 39,216 bottles of Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg. The affected product is identified by Batch# H900575 and an expiration date of 01/2022. The medication is manufactured by Lupin Limited in Pithampur, India, and distributed by Lupin Pharmaceuticals in Baltimore, MD.
The recall was initiated due to the presence of a foreign substance. Product complaints reported brownish or blackish stains on the tablets and brownish or blackish powder observed inside the bottles.
The product was distributed to wholesalers, distributors, and supermarket and drug chains throughout the United States. Consumers should check their medication for the specific batch number and expiration date listed above. If the product matches the recall details, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE)
- Brand
- LISINOPRIL AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 39,216
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)
- Batch# H900575
- exp. date 01/2022
UPCs (3)
- 0368180519010
- 0368180518013
- 0368180520016
Distribution
Distribution scope not specified by the agency.
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