The Recall Desk
ModerateFDA (Drugs)·D-0123-2017·Announced 2016-11-09

Par Pharmaceutical Recalls Subpotent Gildess 24 FE 1.5/30 Oral Contraceptives

Par Pharmaceutical is recalling Gildess 24 FE 1.5/30 oral contraceptives because the ethinyl estradiol component is subpotent. The recall covers 44,127 tablets distributed nationwide and in Puerto Rico.

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 III, which indicates a low risk of adverse health consequences. The hazard is a subpotent active ingredient, which is a quality defect rather than a contamination or acute safety hazard like a choking or fire risk.

Plain-English summary

Par Pharmaceutical, Inc. is recalling Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count. The recall involves 44,127 tablets in 3-blisters (NDC 0603-7610-49) and 6-blisters (NDC 0603-7610-17) packaging. The product is prescription-only and was manufactured in Canada by Patheon, Inc. for Qualitest Pharmaceuticals, USA.

The recall is being conducted because the ethinyl estradiol component of the medication is subpotent, meaning it contains less of the active ingredient than labeled. The affected lot numbers are 4082018, 4082019, 4359320, 4461688, 4501285, 4501286, 4028921, 4258629, 4359321, 4461689, 4501287, and 4581736.

The affected products were distributed nationwide and in Puerto Rico. Consumers and healthcare providers should check their inventory for the specific NDC and lot numbers listed above. If the product is found, it should be returned to the supplier or Par Pharmaceutical, Inc. for credit.

The recalled product

Product
Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, (a) 3 blisters (NDC 0603-7610-49), and (b) 6 blisters (NDC 0603-7610-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario,
Manufacturer
Par Pharmaceutical, Inc.
Category
Drug — Oral Contraceptive
Hazard
Affected units
44,127

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 (11)

  • Lot Numbers (a) 4082018
  • 4082019
  • 4359320
  • 4461688
  • 4501285
  • 4501286 (b) 4028921
  • 4258629
  • 4359321
  • 4461689
  • 4501287
  • 4581736

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 5 recalled by Par Pharmaceutical, 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 5 products in this recall →

Related recalls

Same manufacturer · Par Pharmaceutical, Inc.

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Same hazard · subpotent drug

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