drugs MODERATE Updated 2020-11-25

Apotex Corp. recalls Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000

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Recalled Product

Aripiprazole Tablets, USP 15 mg tablets, packaged in a) 1000 count bottle, NDC 60505-2675-8; b) 30 count bottle, NDC 60505-2675-3; Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326

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Hazard / Issue

Failed Dissolution Specifications: Out of specification for dissolution.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: a) PZ6716 Exp. 02/2021; b) PZ6715 Exp. 02/2021

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.

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