Aurobindo Pharma USA Inc. recalls Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA,
Aurobindo Pharma recalls 7.5mg Olanzapine tablets due to failed impurities and degradation. Rx-only bottles with specific lot number and expiration date are affected. Consumers should contact the manufacturer for details.
Recall notice
Failed Impurities/ Degradation Specifications
Contact the company & request your remedy
What happened, in plain English
Aurobindo Pharma is recalling 7.5mg Olanzapine tablets that may have failed impurities or degradation. This could pose a risk to patients taking the medication, so affected individuals should contact the manufacturer for guidance. Read more at govinfonow.com/recall/37099-aurobindo-olanzapine-7-5mg-tablets-recall-failed-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37099-aurobindo-olanzapine-7-5mg-tablets-recall-failed-impurities-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1315-2020
Cite this page
“Aurobindo Olanzapine 7.5mg Tablets Recall: Failed Impurities Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37099-aurobindo-olanzapine-7-5mg-tablets-recall-failed-impurities-risk. Based on FDA recall #D-1315-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1315-2020%22&limit=1).
Why it’s dangerous
The tablets may contain impurities or degrade, which could affect the medication's safety and effectiveness. This could lead to unintended health effects for patients taking the medication.
Who’s affected
Patients prescribed this medication by a healthcare provider. Those with the specific lot number (563180012A1) and expiration date (8/2020) are most at risk.
How to tell if you have this one
Check for the lot number 563180012A1 and expiration date 8/2020 on the bottle. The product is a 30-count prescription-only tablet bottle manufactured by Aurobindo Pharma.
- Brand
Aurobindo Pharma- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
U.S.A. Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1314-2020 | Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30; Lot #: 561180046A1, Exp 8/2020 | 13322 bottles |
| D-1315-2020 | Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-682-30; Lot #: 563180012A1, Exp 8/2020 | 7547 bottles |
What to do — step by step
Contact Manufacturer
Reach out to Aurobindo Pharma USA Inc for specific guidance on the recall and next steps.
Questions people ask
Is this product safe to use?
The recall indicates potential impurities or degradation, so it is not recommended to use these tablets without contacting the manufacturer first.
What should I do if I have this product?
Contact Aurobindo Pharma USA Inc for instructions on what to do with the recalled product.
How can I check if I have the recalled product?
Look for the lot number 563180012A1 and expiration date 8/2020 on the 30-count prescription bottle.
Contact Aurobindo Pharma
We’ve drafted a message you can send Aurobindo Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-1315-2020 — Aurobindo Pharma Aurobindo Pharma Hello, I own a Aurobindo Pharma that is covered by recall D-1315-2020 from Aurobindo Pharma. 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.
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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-1315-2020 (May 26, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1315-2020 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.