The Recall Desk
ModerateFDA (Drugs)·D-0660-2017·Announced 2017-04-19

FDA Recalls Levonorgestrel Bulk Drug Due to cGMP Deviations

The FDA is recalling bulk levonorgestrel manufactured by Qinhuangdao Zizhu Pharmaceutical due to cGMP deviations and lack of quality assurance.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which is typically associated with a temporary or medically reversible adverse health consequence. The source text cites cGMP deviations and lack of quality assurance but does not report specific illnesses, injuries, or deaths, aligning with a Moderate severity rating for a voluntary precautionary recall of a bulk pharmaceutical ingredient.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Levonorgestrel Non-Micronized, USP, Bulk, which is intended for prescription compounding. The product is manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd. in China and carries the NDC 44132-012-01.

The recall is being conducted because of Current Good Manufacturing Practice (cGMP) deviations and a lack of quality assurance. The specific batch involved is 70001602009, with a date of 2/21/2021.

The product was distributed to New York, Texas, South Carolina, Colorado, Minnesota, and New Jersey. Because this is a bulk ingredient for prescription compounding, it is not typically sold directly to consumers. Pharmacies and compounding facilities should stop using the affected product and follow FDA guidance for disposal or return.

The recalled product

Product
Levonorgestrel Non-Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-012-01),
Manufacturer
Qinhuangdao Zizhu Pharmaceutical, Co.
Category
Drug — Bulk Pharmaceutical Ingredient
Hazard

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 (2)

  • Batch 70001602009
  • 2/21/2021

Distribution

Distributed in 6 states:

Part of a larger recall action

This product is one of 7 recalled by Qinhuangdao Zizhu Pharmaceutical, Co. 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 7 products in this recall →

Related recalls

Same manufacturer · Qinhuangdao Zizhu Pharmaceutical, Co.

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Same hazard · cGMP deviation

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