The Recall Desk
HighFDA (Drugs)·D-0794-2021·Announced 2021-09-22

Oxycodone Hydrochloride Tablets Recalled for Foreign Tablet Contamination

Rhodes Pharmaceuticals is recalling Oxycodone Hydrochloride 10 mg tablets (Lot # WP5K0Y) distributed nationwide after a foreign Hydrochlorothiazide/Lisinopril tablet was found in one bottle.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a high-risk contamination scenario—a foreign prescription drug in an oxycodone bottle creates immediate potential for serious harm through accidental ingestion of an incorrect medication. The source explicitly describes contamination with a foreign tablet, which presents a clear risk of injury even though no illnesses are reported in the source text.

Plain-English summary

Rhodes Pharmaceuticals, L.P. is recalling Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottles (NDC 42858-002-01, Lot # WP5K0Y, expiration date 02/28/2023) because a single foreign tablet containing Hydrochlorothiazide/Lisinopril 25/20 was discovered in one bottle during quality control.

The affected product was manufactured by Purdue Pharma L.P. in Stanford, CT and distributed nationwide. A total of 55,344 bottles of the 100 count size are subject to this recall.

Patients or healthcare providers who have this medication should stop use and contact Rhodes Pharmaceuticals or their healthcare provider if they have any questions or concerns about this recall.

The recalled product

Product
OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
Brand
OXYCODONE HYDROCHLORIDE
Manufacturer
Rhodes Pharmaceuticals, L.P.
Hazard
  • foreign-object-contamination
  • wrong-medication-dispensing

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 # WP5K0Y
  • exp. date 02/28/2023

UPCs (5)

  • 0342858002011
  • 0342858005012
  • 0342858004015
  • 0342858001014
  • 0342858003018

Distribution

Distributed nationwide across the United States.

Same brand · OXYCODONE HYDROCHLORIDE