The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1515-2020·Announced 2020-08-26

Calvin Scott Recalls Hydrochlorothiazide Tablets Due to Packaging Defect

Calvin Scott & Co. is recalling Hydrochlorothiazide 25mg tablets because light-sensitive products were repackaged in transparent pouches.

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, and the hazard involves a packaging defect (transparent pouches for light-sensitive drugs) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Calvin Scott & Company, Inc. is recalling Hydrochlorothiazide (HCTZ) Orange Tabs 25mg, manufactured by Unichem Pharmaceuticals. The recall involves Lot # 19260H with an expiration date of 1/21. The product was distributed nationwide within the United States.

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.

Consumers who have this specific lot of Hydrochlorothiazide should stop using it and contact their pharmacist or healthcare provider for guidance on replacement medication.

The recalled product

Product
Hydrochlorothiazide (HCTZ) Orange Tabs 25mg, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by Unichem Pharmaceuticals, NDC 29300-0128-10
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 (2)

  • Lot #: 19260H
  • Exp. Date: 1/21

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 →

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