Fluoxetine 20mg Capsules (Teva) – Odor Contamination (2014)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.
Brand
Teva Pharmaceuticals USA
Lot Codes / Batch Numbers
Lot #: a) 6A211150, 6A211151, 6A211152, 6A211153, 6A211154, Exp 11/15, 6A212083, 6A212084, 6A212085, 6A212086, Exp 12/15, b) 6A211143, 6A211145, 6A211146, 6A211147, Exp 11/15, c) 6A209116, 6A209117, 6A209118, 6A209119, 6A209120, Exp 09/15, 6A211139, 6A211140, 6A211141, Exp 11/15, 6A212087, Exp 12/15, d) 6A209124, Exp 09/15, 6A211144, 6A211148, 6A211149, Exp 11/15
Products Sold
Lot #: a) 6A211150, 6A211151, 6A211152, 6A211153, 6A211154, Exp 11/15; 6A212083, 6A212084, 6A212085, 6A212086, Exp 12/15; b) 6A211143, 6A211145, 6A211146, 6A211147, Exp 11/15; c) 6A209116, 6A209117, 6A209118, 6A209119, 6A209120, Exp 09/15; 6A211139, 6A211140, 6A211141, Exp 11/15; 6A212087, Exp 12/15; d) 6A209124, Exp 09/15; 6A211144, 6A211148, 6A211149, Exp 11/15
Teva Pharmaceuticals USA is recalling Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bo due to Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026