Class II · Moderate risk
Aripiprazole Tablets USP
Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Aripiprazole Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
Affected NDCs
60505-2676-03
60505-2676-08
Compare with the code on your package — it is the most precise check available.
Drug: Aripiprazole
- Recalling firm
- Apotex Corp.
- NDC code
- 60505-2676-8
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1285-2022 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Aripiprazole recalls
See all
Class II · Moderate risk
Aripiprazole Tablets
Superpotent drug
Class III · Low risk
Abilify (aripiprazole)
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Class III · Low risk
Abilify (aripiprazole)
Cross Contamination with Other Products
Class III · Low risk
Abilify (aripiprazole)
Cross Contamination with Other Products
Other recalls by Apotex Corp.
All 2022 recalls
Class II · Moderate risk
Paxil CR
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Class II · Moderate risk
Desmopressin Nasal Spray
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Class II · Moderate risk
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*
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Class II · Moderate risk
Ketorolac Tromethamine Ophthalmic Solution
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