The Recall Desk
ModerateFDA (Drugs)·D-1530-2020·Announced 2020-08-26

Calvin Scott Recalls Phentermine HCL Tablets Due to Packaging Deviations

Calvin Scott & Company is recalling specific lots of Phentermine HCL tablets because light-sensitive products were repackaged in transparent pouches.

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: The recall is classified as FDA Class II, and the hazard involves a packaging deviation (transparent pouches for light-sensitive drugs) without reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Calvin Scott & Company, Inc. is recalling specific lots of Phentermine HCL White/Blue Speck Tabs 37.5 mg, 28-count bags. The product is distributed by Calvin Scott & Co., Inc. in Albuquerque, NM, and manufactured by SUN Pharmaceuticals. The recall covers lots 19207, 19251, 19284, and 19316 with expiration dates ranging from September 2020 to December 2020.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the light-sensitive drug products were repackaged in transparent or partially transparent pouches, which may not provide adequate protection from light exposure.

The affected products were distributed nationwide within the United States. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on replacement or disposal.

The recalled product

Product
Phentermine HCL White/Blue Speck Tabs 37.5 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by SUN Pharmaceuticals, NDC 53489-0676-10
Manufacturer
Calvin Scott & Company, Inc.
Category
Drug — Prescription Medication
Hazard

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 (8)

  • Lot #:19207
  • Exp. Date: 9/21
  • 19251
  • Exp. Date: 9/20
  • 19284
  • Exp. Date:10/20
  • 19316
  • Exp. Date: 12/20

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 19 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 19 products in this recall →

Related recalls

Same manufacturer · Calvin Scott & Company, Inc.

See all →

Same hazard · packaging defect

See all →