Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceutical...

FDA Drug Recall #D-1077-2018 — Class II — August 13, 2018

Recall Summary

Recall Number D-1077-2018
Classification Class II — Moderate risk
Date Initiated August 13, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Lupin Pharmaceuticals Inc.
Location Baltimore, MD
Product Type Drugs
Quantity 11,706 bottles

Product Description

Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, NDC 68180-980-03

Reason for Recall

Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.

Distribution Pattern

Product was distributed to distributors, mail order pharmacy and supermarkets throughout the United States.

Lot / Code Information

Lot #: H800414, Exp. 12/2019

Other Recalls from Lupin Pharmaceuticals Inc.

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D-0220-2026 Class II Ganirelix Acetate Injection, 250 mcg/0.5mL, Sin... Nov 13, 2025
D-0227-2026 Class II Sertraline Hydrochloride Tablets USP, 100 mg, 9... Nov 5, 2025
D-0542-2025 Class II Amlodipine and Benazepril HCl Capsules USP 2.5 ... Jul 2, 2025
D-0537-2025 Class II clomiPRAMINE Hydrochloride Capsules USP 25 mg, ... Jun 27, 2025

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.