Class II · Moderate risk
Fluoxetine Tablets
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Is Fluoxetine recalled?
New recall announced
announced by the firm and posted by FDA; not yet in FDA’s classified recall data
-
Lipofit Extreme 2.0 Fat Burner Dietary Supplement
· Ana Salazar Modela Tu Cuerpo Inc. ·
Reason Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)
Fluoxetine was recalled 11 times before this announcement; all of those are closed.
Most common reason: Chemical / undeclared (5 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Fluoxetine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Fluoxetine recalls on record
none so far in 2026; 11 on record, newest first
Class II · Moderate risk
Fluoxetine Tablets
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
Class III · Low risk
Fluoxetine Tablets USP
Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.
Class II · Moderate risk
Fluoxetine Capsules USP
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
Class II · Moderate risk
Fluoxetine Capsules USP
Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.
Class III · Low risk
Fluoxetine Capsules USP
Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
Class II · Moderate risk
Fluoxetine Hydrochloride active pharmaceutical ingredient…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Fluoxetine Capsules
Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor.
Class II · Moderate risk
Fluoxetine Capsules USP
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Class II · Moderate risk
Fluoxetine Capsules USP
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Class II · Moderate risk
FLUoxetine HCl Capsule
Labeling: Label Mixup; FLUoxetine HCl, Capsule, 10 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: AD70585_10, EXP: 5/29/2014.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.