The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0119-2017·Announced 2016-11-09

Par Pharmaceutical Recalls Subpotent Gildess 1.5/30 Oral Contraceptive Tablets

Par Pharmaceutical is recalling Gildess 1.5/30 tablets because they contain subpotent levels of ethinyl estradiol. The recall covers specific lots distributed nationwide and in Puerto Rico.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 the violation is not likely to cause adverse health consequences. The hazard is subpotency, which is a quality issue rather than an acute safety hazard like contamination or mislabeling of a critical allergen.

Plain-English summary

Par Pharmaceutical, Inc. is recalling Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, Rx only. The recall is due to the presence of subpotent levels of ethinyl estradiol in the affected tablets. The product was manufactured in Canada by Patheon, Inc. for Qualitest Pharmaceuticals, USA.

The recall affects 221,017 tablets from specific lot numbers, including 4169949, 4297235, and others listed in the agency notice. These products were distributed nationwide and in Puerto Rico. The affected NDCs are 0603-7606-48 (3 blisters) and 0603-7606-15 (6 blisters).

Consumers and healthcare providers should check their inventory or prescriptions for these specific lot numbers. If the product matches the recalled lots, it should be returned to the pharmacy or supplier for credit. Patients should consult their healthcare provider for alternative contraceptive options if they are using the affected product.

The recalled product

Product
Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7606-48) and (b) 6 blisters (NDC 0603-7606-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST…
Manufacturer
Par Pharmaceutical, Inc.
Category
Drug — Oral Contraceptive
Hazard
Affected units
221,017

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 (20)

  • Lot Numbers (a) 4169949
  • 4297235
  • 4359298
  • 4501268
  • 4614353 (b) 4101064
  • 4196576
  • 4228443
  • 4265206
  • 4265207
  • 4267685
  • 4365281
  • 4365284
  • 4365289
  • 4501276
  • 4563354
  • 4563355
  • 4614354
  • 4731574
  • 4731575
  • 4793332

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 →

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