The Recall Desk
ModerateFDA (Drugs)·D-0692-2022·Announced 2022-03-30

Hydrocortisone Butyrate Lotion Recalled Due to cGMP Deviations

Teligent Pharma is recalling Hydrocortisone Butyrate Lotion 0.1% nationwide due to cGMP deviations. The firm discontinued its stability study program, prompting recall of all products within expiry.

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: This is an FDA Class II recall involving a cGMP deviation (discontinuation of stability studies). No illnesses, injuries, or safety incidents are reported in the source text. The hazard is procedural/compliance-based rather than involving reported harm or high-risk contamination.

Plain-English summary

Teligent Pharma, Inc. is recalling Hydrocortisone Butyrate Lotion, 0.1%, distributed nationwide in the USA and Puerto Rico. The affected product is supplied in 2 fl oz (59 mL) bottles (NDC 52565-087-02) and 4 fl oz (118 mL) bottles (NDC 52565-087-04). A total of 30,497 bottles are being recalled.

The recall was initiated because the firm is discontinuing its stability study program, which constitutes a deviation from current good manufacturing practices (cGMP). All products within expiry dates are included in this recall across all affected batch numbers.

Consumers who have this medication should consult their healthcare provider or pharmacist about what to do with their product and whether an alternative medication is needed. This is a prescription drug (Rx only); patients should not discontinue use without guidance from their healthcare provider.

The recalled product

Product
Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bottles, NDC 52565-087-04, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Manufacturer
Teligent Pharma, Inc.
Category
Drug — Topical Corticosteroid
Hazard
Affected units
30,497

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 (13)

  • Batch: a) 16293
  • Exp. 1/31/2023
  • 16436
  • 16451
  • Exp. 2/28/2023
  • b) 15105
  • Exp. 2/28/2022
  • 15290
  • 15291
  • 15292
  • Exp. 3/31/2022
  • 16293
  • 16472

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 37 recalled by Teligent Pharma, 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 37 products in this recall →

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