The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0039-2015·Announced 2014-10-29

Qualitest Recalls Children's Acetaminophen Suspension for Assay Failure

Qualitest Pharmaceuticals is recalling Children's Q-PAP Acetaminophen Oral Suspension due to a failure of the product assay at the 12-month timepoint.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly identifies the issue as a 'Superpotent Drug' failure, which implies a significant risk of overdose or serious injury, aligning with the 'Severe' criteria for significant injury reports or high-risk defects.

Plain-English summary

Qualitest Pharmaceuticals is initiating a recall of Children's Q-PAP Acetaminophen Oral Suspension, Grape Flavor, 160mg/5mL. The recall involves 17,011 units of the 4 FL OZ (118 mL) bottles, which were distributed nationwide.

The recall was initiated because the product failed the assay test at the 12-month timepoint. The source text identifies this as a "Superpotent Drug" issue, indicating the medication may contain more active ingredient than intended. Specific lot codes affected include L084G12A, L097K12A, L001B13A, L001B13B, L079D13A, L102G13A, and L007J13A.

Consumers should check their bottles for the affected codes and stop using the product if it matches the recall description. The FDA has classified this as a Class II recall.

The recalled product

Product
CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, GRAPE FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0843-54, OTC
Manufacturer
Qualitest Pharmaceuticals
Category
Drug — Over-the-Counter Medication
Hazard
Affected units
170,113

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 (7)

  • Codes: L084G12A
  • L097K12A
  • L001B13A
  • L001B13B
  • L079D13A
  • L102G13A
  • L007J13A

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Qualitest Pharmaceuticals 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 3 products in this recall →

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