The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-1123-2022·Announced 2022-06-01

Benzphetamine tablets recalled due to label mix-up with Benzonatate

Calvin Scott & Company recalled Benzphetamine 50mg tablets due to a labeling error where bottles labeled as Benzonatate 100mg capsules contained Benzphetamine 50mg tablets and vice versa. One physician in Alpharetta, Georgia received 13 affected bottles.

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: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is a labeling error resulting in wrong medications in mislabeled bottles; however, since the hazard is theoretical and no adverse effects have been documented, the severity is rated as moderate.

Plain-English summary

Calvin Scott & Company, Inc. is recalling Benzphetamine 50mg tablets due to a labeling error that resulted in incorrect product-to-label matching.

The company discovered that bottles labeled as Benzonatate 100mg capsules actually contained Benzphetamine 50mg tablets, while bottles labeled as Benzphetamine 50mg tablets contained Benzonatate 100mg capsules. This mix-up affects lot CS-20274-005 with an expiration date of May 2022.

The recall affects 13 bottles that were distributed to one physician in Alpharetta, Georgia.

If you have received these bottles, do not use them and contact your pharmacist or physician to verify the contents and receive the correct medication.

The recalled product

Product
Benzphetamine tablets, 50mg, CIII, repackaged in 30-count bottles, Distributed by Calvin Scott & Co., Inc, Albuq., NM. 87123, NDC 10702-0040-50
Manufacturer
Calvin Scott & Company, Inc.
Category
Drug
Hazard
Affected units
13

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 (2)

  • CSI Lot: CS-20274-005
  • Exp 5/22

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by Calvin Scott & Company, 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 2 products in this recall →

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