Alembic Pharmaceuticals Limited recalls Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals recalls 2mg aripiprazole tablets due to label mix-up with 5mg tablets. This could lead to incorrect dosing if taken without proper label check.
Lower-risk recall
Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
Contact the company & request your remedy
What happened, in plain English
Alembic Pharmaceuticals is recalling 2mg aripiprazole tablets that were mislabeled as 2mg but contain 5mg tablets. This risk of incorrect dosing could cause harm if taken without checking the label. Read more at govinfonow.com/recall/37058-alembic-aripiprazole-tablets-2mg-recall-label-mix-up-with-5mg.
Source Summary by GovInfoNow · govinfonow.com/recall/37058-alembic-aripiprazole-tablets-2mg-recall-label-mix-up-with-5mg · Updated October 5, 2026 · FDA enforcement record: FDA #D-1341-2020
Cite this page
“Alembic Aripiprazole Tablets 2mg Recall: Label Mix-Up With 5mg Tablets.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37058-alembic-aripiprazole-tablets-2mg-recall-label-mix-up-with-5mg. Based on FDA recall #D-1341-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1341-2020%22&limit=1).
Why it’s dangerous
The tablets were labeled as 2mg but contain 5mg tablets. If taken without checking the label, patients could receive a higher dose than intended, potentially causing side effects.
Who’s affected
Prescription patients who received the recalled 2mg aripiprazole tablets with 5mg tablets inside. Those at highest risk are patients taking the medication for mental health conditions.
How to tell if you have this one
Check for bottles labeled 'Aripiprazole 2 mg, 30 Tablets per bottle' with the lot number 1905003298, manufactured in India and distributed by Alembic Pharmaceuticals, Inc. in the US.
- Brand
Alembic Pharmaceuticals- Category
Drug
What to do — step by step
Check Label Carefully
Look for the label indicating 5mg tablets inside a bottle marked as 2mg.
Questions people ask
Why is this recall happening?
The tablets were mislabeled as 2mg but contain 5mg tablets, which could lead to incorrect dosing.
How can I tell if I have the recalled product?
Check for bottles labeled 'Aripiprazole 2 mg, 30 Tablets per bottle' with lot number 1905003298, manufactured in India and distributed by Alembic Pharmaceuticals, Inc. in the US.
What should I do if I have the recalled product?
Check the label carefully to ensure you have 2mg tablets. If you find 5mg tablets inside a 2mg-labeled bottle, contact your doctor or pharmacist.
Contact Alembic Pharmaceuticals
We’ve drafted a message you can send Alembic Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1341-2020 — Alembic Pharmaceuticals Alembic Pharmaceuticals Hello, I own a Alembic Pharmaceuticals that is covered by recall D-1341-2020 from Alembic Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1341-2020 (June 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1341-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.