The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0858-2020·Announced 2020-02-19

Contract Pharmacal Recalls Acetaminophen Tablets Due to Foreign Object Contamination

Contract Pharmacal is recalling Major Extra Strength Acetaminophen tablets because a foreign prenatal tablet was found in a bottle.

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: The recall is classified as FDA Class II, and the hazard involves a foreign object (commingled tablet) which poses a risk of accidental ingestion but is not a high-risk pathogen or structural defect.

Plain-English summary

Contract Pharmacal Corporation is recalling Major Extra Strength Acetaminophen Tablets, 500 mg, in 100-count and 1000-count bottles. The recall is due to a complaint that a Women's Prenatal dietary supplement tablet was found commingled in a 1000-count bottle of the acetaminophen product.

The affected product is identified by Lot # 193005 and an expiration date of 08/21. The recall involves 1,176 bottles of the 100-count size and 6,216 bottles of the 1000-count size. The product was distributed nationwide within the United States.

Consumers should check their medicine cabinets for these specific bottles and stop using the product if found. They should contact the manufacturer or their healthcare provider for further instructions.

The recalled product

Product
ACETAMINOPHEN (ACETAMINOPHEN)
Brand
ACETAMINOPHEN
Manufacturer
Contract Pharmacal Corporation
Category
Drug — OTC Analgesic
Hazard

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 (2)

  • Lot #: 193005
  • Exp. Date 08/21

UPCs (3)

  • 0309046730804
  • 309046730606
  • 309046730804

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Contract Pharmacal Corporation 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 2 products in this recall →

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