The Recall Desk
SevereFDA (Drugs)·D-66251-001·Announced 2013-10-09

Watson Recalls Oxycodone and Acetaminophen Tablets Due to Foreign Contamination

Watson Laboratories is recalling Oxycodone and Acetaminophen Tablets because foreign tablets were found in a sealed bottle.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric. The presence of foreign tablets in a sealed bottle poses a significant risk of medication error and potential serious injury.

Plain-English summary

Watson Laboratories, Inc. is recalling 10,615 bottles of Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg. The product is identified by NDC 0591-0825-01, Lot # 705791A, and an expiration date of 04/2015. The bottles contain 100 tablets each and are marked as Rx Only.

The recall was initiated because 20 tablets of a different medication, Oxycodone/APAP 7.5/500 mg, were found inside a sealed 100-count bottle of the recalled 10/650 mg product. This indicates a foreign object or product contamination issue within the packaging.

The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or point of purchase for disposal or credit, as directed by the recalling firm.

The recalled product

Product
Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles, Rx Only, Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA, NDC 0591-0825-01
Affected units
10,615

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 #: 705791A
  • Exp 04/2015

Distribution

Distributed nationwide across the United States.