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Pfizer Inc.

Pfizer Inc. Recalls

All product recalls associated with Pfizer Inc..

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Recall Summary

Total Recalls

120

Past Year

Class I (Serious)

Most Recent

Aug 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 101–120 of 120 recalls

Cardura XL (Pfizer) – Degradation Specification Failure (2014)

Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.

Class IIILow

FDAJun 19, 2014Nationwide• Pfizer Inc.

Tikosyn Capsules (Pfizer) – foreign tablet detected (2014)

Presence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn¿ (dofetilide) 500 mcg (0.5 mg).

Class IIModerate

FDAApr 8, 2014Nationwide• Pfizer Inc.

Fluconazole Suspension (Pfizer) – Container Defect (2014)

Defective Container: Tamper evident ring failures discovered on some bottles.

Class IIModerate

FDAJan 29, 2014Nationwide• Pfizer Inc.

Zithromax (Pfizer) – Impurity Specification Failure (2014)

Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.

Class IIILow

FDAJan 2, 2014Nationwide• Pfizer Inc.

Glucotrol XL (Pfizer) – dissolution failure (2013)

Failed Dissolution Specification; 8 hr stability timepoint

Class IIILow

FDANov 4, 2013Nationwide• Pfizer Inc.

Prempro (Pfizer) – Failed Dissolution Specs (2013)

Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the specification for conjugated estrogens dissolution.

Class IIILow

FDAMay 31, 2013Nationwide• Pfizer Inc.

Norpace CR (Pfizer) – Dissolution Failure (2013)

Failed Dissolution Specification

Class IIILow

FDAMay 31, 2013Nationwide• Pfizer Inc

Prempro (Pfizer) – Failed Dissolution Specs (2013)

Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the dissolution specification for conjugated estrogens.

Class IIILow

FDAMay 31, 2013Nationwide• Pfizer Inc.