Sandoz Fluoxetine Capsules Recall: FDA Class III

Why it was recalled

Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.

Product description

Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01

Lot numbers, UPCs & expiration codes

Lot ET5122, Exp. 10/17

Where it was sold

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0291-2015
Classification: Class III
Status: Terminated
Recall initiated: Dec 5, 2014
FDA report date: Dec 17, 2014
Quantity: 1,008 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Sandoz Incorporated

Original FDA data

Every field from FDA enforcement report D-0291-2015, exactly as published.

Show all FDA fields

City: Broomfield
State: CO
Status: Terminated
Country: United States
Event ID: 69942
Address: 2555 W Midway Blvd
Code information: Lot ET5122, Exp. 10/17
Postal code: 80020-1632
Report date: Dec 17, 2014
Product type: Drugs
Recall number: D-0291-2015
Classification: Class III
Recalling firm: Sandoz Incorporated
Product quantity: 1,008 bottles
Termination date: Jun 24, 2015
Reason for recall: Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01
Distribution pattern: AZ
Recall initiation date: Dec 5, 2014
Initial firm notification: Letter
Center classification date: Dec 9, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0291-2015, published Dec 17, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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Sandoz Fluoxetine Capsules Recall

Summary