The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1280-2020·Announced 2020-06-03

CVS Lidocaine Cold and Hot Patch Recalled for Manufacturing Record Loss

CVS Pharmacy is recalling Maximum Strength Lidocaine Cold & Hot Patches because manufacturing records and samples were lost, meaning the product may not remain within specification through its expiration date.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 II, which typically indicates a reasonable probability that use of the product will not cause serious adverse health consequences. The hazard is a lack of assurance regarding product stability due to lost records, rather than a confirmed contamination or defect causing injury.

Plain-English summary

CVS Pharmacy, Inc. is recalling 72,600 boxes of Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%). The product is distributed nationwide in the USA and is manufactured by Wuhan Bingbing Pharmaceutical Co., Ltd. The recall involves specific batches with expiration dates ranging from June 2020 to March 2021.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lost product manufacturing records and retained product samples. As a result, there is no assurance that the product will remain within specification through the labeled expiration date.

Consumers who have purchased these patches should stop using them and return them to the place of purchase for a refund or follow instructions from CVS Pharmacy.

The recalled product

Product
Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 patches per box, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895; NDC 66902-218-05.
Manufacturer
Wuhan Bingbing Pharmaceutical Co., Ltd.
Category
Drug — Topical Analgesic
Hazard
Affected units
72,600

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 (18)

  • Batch #: 170614
  • Exp 2020.06.13
  • 180108
  • Exp 2021.01.07
  • 180109
  • Exp 2021.01.08
  • 180110
  • Exp 2021.01.09
  • 180111
  • Exp 2021.01.10
  • 180112
  • Exp 2021.01.11
  • 180113
  • Exp 2021.01.12
  • 180317
  • Exp 2021.03.16
  • 180318
  • Exp 2021.03.17

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Wuhan Bingbing Pharmaceutical Co., Ltd. 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 4 products in this recall →

Related recalls

Same manufacturer · Wuhan Bingbing Pharmaceutical Co., Ltd.

See all →

Same hazard · cgmp deviation

See all →

Similar recalls