Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactur...
FDA Drug Recall #D-0542-2025 - Class II, July 2, 2025
Recall Summary
| Recall Number | D-0542-2025 |
| Classification | Class II - Moderate risk |
| Date Initiated | July 2, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Lupin Pharmaceuticals Inc. |
| Location | Naples, FL |
| Product Type | Drugs |
| Quantity | 7668 bottles |
Product Description
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA, NDC 68180-755-01.
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Distribution Pattern
Nationwide in the US
Lot / Code Information
Lot GB01616, expiration 2/28/2027
Other Recalls from Lupin Pharmaceuticals Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0723-2026 | Class II | Glucagon Emergency Kit for Low Blood Sugar, Glu... | Jun 23, 2026 |
| D-0655-2026 | Class II | prednisoLONE Acetate Ophthalmic Suspension, USP... | Jun 4, 2026 |
| D-0541-2026 | Class II | Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx... | Apr 24, 2026 |
| 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 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.
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.