Agency classClass IIOur severity:Moderate FDA (Food)·F-0916-2013·Announced 2013-01-30

Cardinal Health Recalls Dairy Aid Lactase Caplets Due to Labeling Error

Cardinal Health is recalling specific lots of Dairy Aid Lactase Enzyme Supplement caplets because the packaging incorrectly lists the strength as 9,000 FCC Units instead of 3,000 FCC Units.

The agency’s classification

FDA (Food): 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, but the source text identifies the issue as a labeling error regarding strength without reporting any illnesses or injuries. This aligns with the rubric for minor labeling errors or low-risk contamination.

Plain-English summary

Cardinal Health is voluntarily recalling specific lots of Dairy Aid Lactase Enzyme Supplement, 3,000 FCC Units, 60 caplets. The recall was initiated after the firm discovered that the product labeling bears an incorrect strength of 9,000 FCC Units per caplet, whereas the actual strength is 3,000 FCC Units per caplet.

The affected product is identified by the NDC 55154-1335-4 and is described as a white, oblong caplet imprinted with RP143. The recall covers specific batches and lot numbers with expiration dates ranging from November 2012 to July 2013. The total quantity involved in the recall is 1,140 caplets.

The product was distributed to New Jersey and New York. Consumers who have purchased these specific lots should check their packaging for the listed strength and lot numbers. If the product matches the recalled description, consumers should stop using it and contact Cardinal Health for a refund or further instructions.

The recalled product

Product: Dairy Aid Lactase Enzyme Supplement, Caplet, 3,000 FCC Units, 60 caplets, OTC, Repackaged by: Cardinal Health, Zanesville, OH 43701, NDC 55154-1335-4
Manufacturer: Cardinal Health
Category: Drug — Over-the-Counter Supplement
Hazard: mis-labeling
Affected units: 1,140

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 (20)

White
oblong caplet
imprinted RP143
Batch# M675030
Lot # 10627AA
Exp Date 11/2012
Batch# M679370
Lot # 10627BA
Exp Date 12/2012
Batch# M675020
Lot # 10627A
Batch# M679360
Lot # 10627B
Batch# M707960
Lot # 10627C
Exp Date 3/2013
Batch# M712800
Lot # 11469A
Batch# M740490
Lot # 11464B

Distribution

Distributed in 2 states:

Same manufacturer · Cardinal Health

See all →

High
Dover Closed Urethral Tray Recalled for Potential Drainage Blockage Risk
FDA (Devices) · 2022-12-14
High
Dover Urethral Catheter Drainage System Recall for Potential Port Blockage
FDA (Devices) · 2022-12-14
High
Dover Urinary Catheter Drainage Tray Recall Due to Blockage Risk
FDA (Devices) · 2022-12-14
High
Dover Closed Urethral Tray Recalled Due to Drainage Port Blockage Risk
FDA (Devices) · 2022-12-14
High
Dover urinary catheter drainage bag occlusion defect nationwide recall
FDA (Devices) · 2022-12-14

Same hazard · mis labeling