The Recall Desk
LowFDA (Drugs)·D-631-2013·Announced 2013-07-10

Pfizer Recalls Prempro Tablets Due to Dissolution Specification Failures

Pfizer is recalling specific lots of Prempro tablets because they may not meet dissolution specifications for conjugated estrogens.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The agency classified this as an FDA Class III recall, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or specification issues without reported harm.

Plain-English summary

Pfizer Inc. is recalling specific lots of Prempro (conjugated estrogens/medroxyprogesterone acetate) tablets. The recall is being conducted because certain lots of the product may not meet the specification for conjugated estrogens dissolution.

The affected product consists of 0.625 mg/5.0 mg tablets, packaged in 1 blister card containing 28 tablets. The specific lots involved are E77055, E96153, and F11111, all with an expiration date of 06/13. The total quantity recalled is 135,520 blister cards.

These products were distributed nationwide and in Puerto Rico. Consumers and healthcare providers should check their medication for these specific lot numbers and expiration dates. If the medication matches the recalled description, they should contact their healthcare provider or pharmacist for guidance on replacement or disposal.

The recalled product

Product
Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.0 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA 1910, NDC 0046-0975-11
Manufacturer
Pfizer Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
135,520

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lots: E77055
  • E96153
  • & F11111 Exp: 06/13

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Pfizer Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Pfizer Inc.

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Same hazard · dissolution failure

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