The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-1254-2014·Announced 2014-04-30

P&L Developments Recalls Subpotent Day Time Cold & Flu OTC Drug

P&L Developments, LLC is recalling 2,500,510 bottles of Day Time Cold & Flu because the phenylephrine component is subpotent.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 III, which indicates the product is not likely to cause adverse health consequences. The hazard is a subpotent drug, which is a quality issue rather than a direct safety hazard like contamination or mislabeling of a common allergen.

Plain-English summary

P&L Developments, LLC is recalling 2,500,510 bottles of Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, OTC drug products. The recall is due to the phenylephrine component being subpotent, meaning it contains less of the active ingredient than labeled.

The affected products are distributed nationwide in the US under various brand names, including Aaron Health, Best Choice, CareOne, equate, and Publix. The recall covers multiple bottle sizes (4, 6, 8, 10, and 12 oz) and specific lot numbers listed in the agency's structured data.

Consumers should check their medication bottles for the affected lot numbers and brand names. If the product is part of the recall, consumers should stop using it and return it to the place of purchase or contact the manufacturer for instructions.

The recalled product

Product
Day Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, 4, 6, 8, 10, and 12 oz Bottles, OTC Only. Labeled A) Aaron Health, 10 FL OZ, Manufactured by Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; B) Aaron…
Manufacturer
P&L Developments, LLC
Category
Drug — OTC Cold & Flu
Hazard
Affected units
2,500,510

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)

  • Lot # (expiry): Aaron Health A-D) 72493 (5/14)
  • 75241 (7/14)
  • 77879 (8/14)
  • 78795 (9/14)
  • 81058 (11/14)
  • 81118 (10/14)
  • 81578 (10/14)
  • 82076 (10/14)
  • 82023 (11/14)
  • 140756 (1/15)
  • 141655 (11/14)
  • 141882 (3/15)
  • 142086 (2/15)
  • 144257 (1/15)
  • 147361 (3/15)
  • 148288 (6/15)
  • 149143 (7/15)
  • 149512 (7/15)
  • 149741 (8/15)
  • 150307 (9/15)

Distribution

Distributed nationwide across the United States.

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