US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 2, 2013 (13 years ago)

Oxybutynin Chloride

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Labeling: Label Mixup: OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg) may have potentially been mislabeled as the following drug: PIMOZIDE, Tablet, 1 mg (1/2 of 2 mg), NDC 57844018701, Pedigree: AD73525_61, EXP: 5/30/2014.

What was recalled

OXYBUTYNIN CHLORIDE, Tablet, 2.5 mg (1/2 of 5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00603497521

Recalling firm
Aidapak Services, LLC
Origin
WA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-987-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Chloride recalls

See all
Class II · Moderate risk Ongoing

Clindamycin Palmitate Hydrochloride for Oral Solution

Reason Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.

Heritage Pharmaceuticals Inc NDC 23155-603-51 D-0768-2026
Class II · Moderate risk Ongoing

Dicyclomine Hydrochloride Capsules

Reason shortfill; reports of empty capsules.

Aurobindo Pharma USA Inc NDC 59651-719-99 D-0733-2026
Class II · Moderate risk Ongoing

Naropin

Reason Presence of Particulate Matter: Hair was found in products

Fresenius Kabi USA, LLC D-0727-2026
Class II · Moderate risk Ongoing

Rohto Cooling Eye Drops Cool Relief

Reason Lack of Assurance of Sterility

Rohto-Mentholatum (Vietnam) Co., Ltd. NDC 10742-8141-1 D-0722-2026
Class II · Moderate risk Ongoing

Rohto Cooling Eye Drops Optic Glow

Reason Lack of Assurance of Sterility

Rohto-Mentholatum (Vietnam) Co., Ltd. NDC 10742-8160-1 D-0718-2026