Legacy Pharmaceutical Packaging, LLC
NDC labeler code: 68645
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- LisinoprilZestril, Qbrelis · 6 products
- Metformin hydrochlorideGlumetza · 4 products
- Lisinopril and hydrochlorothiazideZestoretic · 3 products
- Sertraline hydrochlorideZoloft · 3 products
- AmlodipineNorvasc, Sdamlo, Norliqva · 3 products
- Enalapril maleateVasotec, Epaned · 3 products
- MetoprololToprol XL, Lopressor, Kapspargo · 2 products
- IbuprofenIbu, Caldolor · 2 products
- GlipizideGlucotrol XL · 2 products
- EscitalopramLexapro · 2 products
- Lovastatin2 products
- FluoxetineProzac · 2 products
- HydrochlorothiazideInzirqo · 1 product
- ClopidogrelPlavix · 1 product
- FamotidinePepcid · 1 product
- FinasteridePropecia, Proscar · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| March 16, 2018 | ANDA209313 | Metformin hydrochloride METFORMIN HYDROCHLORIDE | Granules |
| September 15, 2015 | ANDA091625 | Ibuprofen IBUPROFEN | Granules |
| September 11, 2012 | ANDA078604 | Escitalopram ESCITALOPRAM OXALATE | Invagen Pharms |
| May 17, 2012 | ANDA090540 | Clopidogrel CLOPIDOGREL BISULFATE | Aurobindo Pharma Ltd |
| June 7, 2010 | ANDA090061 | Finasteride FINASTERIDE | Hetero Labs Ltd III |
| April 22, 2010 | ANDA090564 | Metformin hydrochloride METFORMIN HYDROCHLORIDE | Granules India |
| April 8, 2009 | ANDA078552 | Amlodipine AMLODIPINE BESYLATE | Epic Pharma LLC |
| November 1, 2007 | ANDA078296 | Lovastatin LOVASTATIN | Lupin |
| September 11, 2007 | ANDA077739 | Metoprolol METOPROLOL TARTRATE | Aurobindo Pharma |
| August 28, 2007 | ANDA077955 | Amlodipine AMLODIPINE BESYLATE | Invagen Pharms |
| February 6, 2007 | ANDA077397 | Sertraline hydrochloride SERTRALINE HYDROCHLORIDE | Invagen Pharms |
| September 27, 2006 | ANDA077912 | Lisinopril and hydrochlorothiazide LISINOPRIL AND HYDROCHLOROTHIAZIDE | Lupin |
| July 1, 2002 | ANDA075903 | Lisinopril LISINOPRIL | Annora Pharma |
| January 29, 2002 | ANDA076001 | Fluoxetine FLUOXETINE HYDROCHLORIDE | Teva Pharms USA |
| June 13, 2001 | ANDA075795 | Glipizide GLIPIZIDE | Apotex |
| April 16, 2001 | ANDA075718 | Famotidine FAMOTIDINE | DR Reddys Labs Ltd |
| August 22, 2000 | ANDA075479 | Enalapril maleate ENALAPRIL MALEATE | Heritage Pharma |
| January 12, 1973 | ANDA083177 | Hydrochlorothiazide HYDROCHLOROTHIAZIDE | Ivax Sub Teva Pharms |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2024
-
November 15, 2024 · Class II · Terminated · D-0061-2025 · Lisinopril
Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
Lisinopril Tablets, USP 10 mg, 90 tablets per bottle, Rx Only, Distributed by: Walmart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Pack
2023
-
December 11, 2023 · Class II · Ongoing · D-0205-2024 · Sertraline hydrochloride
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Sertraline Tablets, USP 100 mg, 30 tablets per bottle, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, Packaged by: Legacy Pharmaceutical Packaging LLC., Earth City,
2014
-
February 14, 2014 · Class II · Terminated · D-1279-2014 · Fluoxetine
Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor.
Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Bentonville, AR 72716; Manufactured by: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; Packaged by: Legacy Pharmaceutical Packaging
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
- All drug companiesA to Z
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026