Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class III · Low risk Terminated Initiated Mar 18, 2021 (6 years ago)

Sp-4

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.

Cause type: Other

Recalls whose stated reason does not fall into the categories above. See the recall's own reason text for the specifics. All other recalls.

What was recalled

Sp-4, 100 mL solution bottles, Rx only, Washington Homeopathic Products, Inc.260 J R Hawvermale Way Berkeley Springs West Virginia 25411

Recalling firm
Washington Homeopathic Products, Inc.
Origin
WV, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0322-2021 · FDA notice

Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other recalls by Washington Homeopathic Products, Inc.

All 2021 recalls
Class III · Low risk

Complete 30C/200C Homeopathic Kit

Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C.

Terminated Labeling / mix-up Washington Homeopathic Products, Inc. D-0618-2024
Class II · Moderate risk

Vaccinotoxinum

cGMP deviations

Terminated cGMP deviation Washington Homeopathic Products, Inc. D-1141-2022
Class II · Moderate risk

Tuberculinum

cGMP deviations

Terminated cGMP deviation Washington Homeopathic Products, Inc. D-1139-2022

Other other recalls from 2021

All other recalls
Class II · Moderate risk

Hydroquinone USP

Finished product specification did not meet USP specifications.

Terminated Other Monarch PCM, LLC NDC 69367-174-01 D-0855-2021
Class II · Moderate risk

Carvedilol 25 mg

A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.

Terminated Other RemedyRepack Inc. NDC 68382-0095-05 D-0754-2021
Class II · Moderate risk

Miss Slim

Marketed without ANDA/NDA approval

Ongoing Other His Enterprise INC D-0770-2021
Class III · Low risk

Asenapine Sublingual Tablets

Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent

Terminated Other SigmaPharm Laboratories LLC NDC 42794-017-10 D-0380-2021