The Recall Desk
ModerateFDA (Drugs)·D-0428-2022·Announced 2022-02-02

BLT Topical Cream recalled by Edge Pharma for CGMP deviations

Edge Pharma is recalling 1,173 jars of BLT Topical Cream (Benzocaine/Lidocaine/Tetracaine) nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary, firm-initiated Class II recall.

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 initiated voluntarily by the firm for CGMP deviations. The source text does not report any illnesses, injuries, or deaths. CGMP deviations are manufacturing/quality-control issues without documented evidence of harm, placing this at the Moderate level per the rubric.

Plain-English summary

Edge Pharma, LLC is recalling BLT Topical Cream (containing Benzocaine 20%, Lidocaine 8%, and Tetracaine 4%) in 60-gram jars nationwide. The recall affects 1,173 jars with specific lot codes and manufacturing dates ranging from December 2021 through April 2022. The product is identified by NDC 05446-1235-01.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary, firm-initiated Class II recall announced via press release on December 6, 2021, and classified by the FDA on January 24, 2022. The recall was terminated on June 7, 2023.

Consumers who have purchased this product should stop using it. Contact Edge Pharma, LLC (856 Hercules Dr., Colchester, VT 05446) for information about the affected lots and next steps. Healthcare providers and patients should refer to the product lot codes provided in the recall notice to determine if their supply is affected.

The recalled product

Product
BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1235-01
Manufacturer
Edge Pharma, LLC
Category
Drug — Topical Anesthetic
Hazard
  • cgmp-deviation

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)

  • 06-2021-10@11 12-07-2021
  • 06-2021-10@9 12-07-2021
  • 06-2021-17@6 12-14-2021
  • 06-2021-17@7 12-14-2021
  • 06-2021-24@5 12-21-2021
  • 06-2021-24@8 12-21-2021
  • 07-2021-01@6 12-28-2021
  • 07-2021-01@7 12-28-2021
  • 07-2021-09@5 01-01-2022
  • 07-2021-09@6 01-05-2022
  • 07-2021-15@5 01-01-2022
  • 07-2021-15@6 01-01-2022
  • 07-2021-22@16 01-19-2022
  • 07-2021-22@8 01-01-2022
  • 07-2021-29@12 01-25-2022
  • 07-2021-29@24 01-25-2022
  • 08-2021-05@7 02-01-2022
  • 08-2021-05@8 02-01-2022
  • 08-2021-19@7 02-15-2022
  • 08-2021-19@8 02-15-2022

Distribution

Distributed nationwide across the United States.

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