CLASS II Drug recall · Reported 7 May 2014 · FDA Enforcement Report
Fluoxetine Capsules, USP, 20 mg recalled by Legacy Pharmaceutical
Legacy Pharmaceutical Packaging is recalling Fluoxetine Capsules, USP, 20 mg, distributed nationwide in the US. The recall was initiated on 14 Feb 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1279-2014
- FDA event ID
- 67526
- Recalling firm
- Legacy Pharmaceutical Packaging, Earth City, MO
- Brand
- Fluoxetine
- Manufacturer
- Legacy Pharmaceutical Packaging, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Feb 2014
- FDA classified
- 28 Apr 2014
- Reported
- 7 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
- Drug class
- Antidepressants
Timeline
| 14 Feb 2014 | Recall initiated by company | |
| 28 Apr 2014 | Classified by FDA | +73 days |
| 7 May 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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 LLC, Earth City, MO 63045, NDC 68645-130-54, UPC 3 68645 13054 5.
Where it was distributed
Nationwide
Stores named: Walmart
Questions about this recall
Is Fluoxetine Capsules, USP, 20 mg recalled?
Yes. Legacy Pharmaceutical Packaging recalled Fluoxetine Capsules, USP, 20 mg on 14 Feb 2014. The recall is Class II and its status is Terminated. Recall number D-1279-2014.
Why was it recalled?
Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor.
Which lots are affected?
Lot numbers: 131328, Exp 08/15; 131634, Exp 09/15; and 131833, Exp 11/15
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Legacy Pharmaceutical Packaging
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sertraline Tablets, USP 100 mg recalled by Legacy PharmaceuticalSertraline Hydrochloride | Legacy Pharmaceutical Packaging | Manufacturing (CGMP) Deviations | AR, CA |
| Drug | CLASS III | Metformin Hydrochloride Tablets USP, 1000 mg recalled | Legacy Pharmaceutical Packaging | Packaging Defects | AR, GA |
| Drug | CLASS II | Losartan Potassium Tablets, USP, 50 mg recalled by Legacy Pharmaceutical | Legacy Pharmaceutical Packaging | Nitrosamine Impurity | AZ, TN |
| Drug | CLASS II | Losartan Potassium Tablets, USP, 50 mg recalled by Legacy Pharmaceutical | Legacy Pharmaceutical Packaging | Nitrosamine Impurity | AZ, IN, TN |
| Drug | CLASS II | Losartan Potassium Tablets, USP, 50 mg recalled by Legacy Pharmaceutical | Legacy Pharmaceutical Packaging | Nitrosamine Impurity | 5 states |
Other Fluoxetine recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fluoxetine Tablets, USP, 20 mg recalled by Torrent PharmaFluoxetine | Torrent Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Fluoxetine Tablets, USP, 20 mg Carton ( Unit-dose) recalledFluoxetine | Torrent Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS III | Fluoxetine Tablets USP, 10 mg recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluoxetine Capsules USP, 10 mg recalled by Teva Pharmaceuticals UFluoxetine | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluoxetine Capsules USP, 20 mg recalled by Teva Pharmaceuticals UFluoxetine | Teva Pharmaceuticals U | Potency & Assay | Nationwide |