Reported Aug 21, 2019 · Terminated
Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin…
Lupin Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lupin Pharmaceuticals Inc. · 111 S Calvert St Fl 21ST · Baltimore, MD · 21202-6174
Is this the product you have?
- Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only
- Manufactured by forLupin Pharmaceuticals, Inc., Baltimore, MD
- Manufactured byLupin Limited, Pithampur, INDIA NDC 68180-518-01
- Lot codes and dates
Batch# H900575exp. date 01/2022
- Amount recalled
- 39,216 bottles
Why it was recalled
Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.
This product could cause temporary or reversible health problems — stop using it.
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