Walmart Amlodipine Besylate Tablets, USP 10 mg, Rx only, 30 tablets, Manufactured by: InvaGen Pha...
FDA Drug Recall #D-319-2013 — Class II — April 22, 2013
Recall Summary
| Recall Number | D-319-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 22, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Legacy Pharmaceutical Packaging LLC |
| Location | Earth City, MO |
| Product Type | Drugs |
| Quantity | 484,236 cartons |
Product Description
Walmart Amlodipine Besylate Tablets, USP 10 mg, Rx only, 30 tablets, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY. Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR. Packaged by: Legacy Pharmaceutical Packaging, LLC, Earth City, MO. NDC 68645-445-70.
Reason for Recall
Labeling: Label Error on Declared Strength-The recalled product has a misprint on the Amoldipine 10 mg label, 5 mg is listed in the USP description. Tablet strength is 10 mg.
Distribution Pattern
Nationwide
Lot / Code Information
Lot # 130251, 130252, 130253 Exp date: 11/14
Other Recalls from Legacy Pharmaceutical Packaging LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0205-2024 | Class II | Sertraline Tablets, USP 100 mg, 30 tablets per ... | Dec 11, 2023 |
| D-1626-2020 | Class III | Metformin Hydrochloride Tablets USP, 1000 mg, 6... | Sep 24, 2020 |
| D-1263-2019 | Class II | Losartan Potassium Tablets, USP, 50 mg, 30 tabl... | Apr 24, 2019 |
| D-1050-2019 | Class II | Losartan Potassium Tablets, USP, 100 mg, 30 tab... | Mar 1, 2019 |
| D-1075-2019 | Class II | Losartan Potassium Tablets, USP, 50 mg, 30 tabl... | Mar 1, 2019 |
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.