# FDA recall D-630-2013

> **Pfizer Inc.** · Class III · drug recall initiated 2013-05-31.

## Product

Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.5 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA, NDC 0046-0875-11

## Reason for recall

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.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-630-2013
- **Recalling firm:** Pfizer Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-05-31
- **Report date:** 2013-07-10
- **Termination date:** 2017-04-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New York, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-630-2013

## Citation

> AI Analytics. FDA recall D-630-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-630-2013. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*