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Pfizer Us Pharmaceutical Group

Pfizer Us Pharmaceutical Group Recalls

All product recalls associated with Pfizer Us Pharmaceutical Group.

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Recall Summary

Total Recalls

148

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 121–140 of 148 recalls

Pristiq Tablets (Pfizer) – foreign tablet mix-up (2014)

Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.

Class IIModerate

FDAApr 16, 2014Nationwide• Pfizer Us Pharmaceutical Group

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.

Effexor XR (Pfizer) – foreign tablet risk (2014)

Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach colored capsule printed TKN250 which was identified as a Tikosyn (dofetilide) capsule.

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Class IHigh

FDAMar 6, 2014Nationwide• Pfizer Us Pharmaceutical Group

Advil PM Caplets (Pfizer) – Subpotent Diphenhydramine (2014)

Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.

Class IIILow

FDAFeb 26, 2014Nationwide• Pfizer Us Pharmaceutical Group

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.

Aldactone Tablets (Pfizer) – Dissolution Profile Issue (2013)

Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.

Class IIModerate

FDASep 4, 2013Nationwide• Pfizer Us Pharmaceutical Group

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.