The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1129-2022·Announced 2022-06-22

Homeopathic Colibacillinum Drug Recall Due to Manufacturing Deviations

Washington Homeopathic Products recalls Colibacillinum homeopathic drug products due to manufacturing practice deviations. The recall involves 206 bottles distributed nationwide; the manufacturer voluntarily initiated it in May 2022.

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: This is an FDA Class II voluntary recall due to manufacturing practice deviations. No specific hazard is described in the source, and no illnesses or injuries have been reported, making this a precautionary manufacturing compliance recall.

Plain-English summary

Washington Homeopathic Products, Inc. is recalling Colibacillinum homeopathic liquid pellets in multiple potencies (12C, 14C, 15C, 18C, 20C, and 30C). The recall involves 206 glass amber bottles labeled with Lot # 21881 that were distributed nationwide.

The recall was initiated due to deviations from current Good Manufacturing Practice (cGMP) requirements. The manufacturer voluntarily initiated the recall on May 13, 2022, and the FDA classified it as a Class II recall.

Consumers who have this product should stop using it and consider returning it to the place of purchase. The recall was terminated on May 25, 2023.

The recalled product

Product
Colibacillinum, Potency: 12C, 14C, 15C, 18C, 20C, 30C, Liquid Pellets, OTC, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411
Affected units
206

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 (1)

  • Lot # 21881

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by Washington Homeopathic Products, 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 17 products in this recall →

Similar recalls