Sun Pharmaceutical Olanzapine Tablets 7.5mg Recall: Impurities Risk
Sun Pharmaceutical recalls 7.5mg Olanzapine tablets with impurities found in specific bottle counts and lot numbers. These tablets may have harmful impurities that could affect safety.
Lower-risk recall
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Contact the company
What happened, in plain English
Sun Pharmaceutical is recalling 7.5mg Olanzapine tablets in specific bottle counts (30-count, 100-count, and 1000-count) due to impurities detected in the drug. This could pose a risk to users if the impurities affect the medication's safety. Read more at govinfonow.com/recall/41791-sun-pharmaceutical-olanzapine-tablets-7-5mg-recall-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41791-sun-pharmaceutical-olanzapine-tablets-7-5mg-recall-impurities-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0700-2017
Cite this page
“Sun Pharmaceutical Olanzapine Tablets 7.5mg Recall: Impurities Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41791-sun-pharmaceutical-olanzapine-tablets-7-5mg-recall-impurities-risk. Based on FDA recall #D-0700-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0700-2017%22&limit=1).
Why it’s dangerous
The tablets contain impurities that failed quality tests. These impurities could potentially affect the medication's safety and effectiveness, though the exact risk level is not specified in the recall.
Who’s affected
People who have the recalled 7.5mg Olanzapine tablets in specific bottle counts and lot numbers are affected. Those taking this medication for mental health conditions are most at risk.
How to tell if you have this one
Check the bottle count: 30-count, 100-count, or 1000-count bottles. Look for lot numbers like JKP3150B (expiring 06/17) or JKP2757A (expiring 05/17).
- Brand
Sun Pharmaceutical- Category
Drug
All 4 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
Nationwide in the USA and Puerto Rico
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0699-2017 | Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-551-18.; Lot #: JKP2751A, Exp 05/17; JKR5048A, Exp 04/18 | 60 bottles |
| D-0700-2017 | Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83), b) 100-count bottles (NDC 62756-553-88), and c) 1000-count bottles (NDC 62756-553-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.; Lot #: a) JKP3150B, Exp 06/17, JKR5749A, Exp 06/18; b) JKP2757A, Exp 05/17, JKP3149A, JKP3150A, Exp 06/17, JKR5049A, Exp 04/18; c) JKP2758B, Exp 05/17 | 6,138 bottles |
| D-0701-2017 | Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83), b) 100-count bottles (NDC 62756-554-88), and c) 1000-count bottles (NDC 62756-554-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India, NDC 62756-551-18.; Lot #: a) JKP1354A, Exp 03/17, JKP2746A, Exp 06/17, JKR5751A, Exp 04/18; b) JKP1355A, Exp 03/17, JKP2738A, JKP3145A, Exp 06/17, JKR5476A, Exp 04/18; c) JKP1353A, Exp 03/17, JKP3146A, JKP2746B, Exp 06/17 | 38,316 bottles |
| D-0702-2017 | Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83), b) 100-count bottles (NDC 62756-556-88), and c) 1000-count bottles (NDC 62756-556-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389, 350 Gujarat, India.; Lot #: a) JKR5759A, Exp 04/18; b) JKP0943A, Exp 04/17, JKR5520A, Exp 04/18; c) JKP0988A, Exp 04/17 | 14,784 bottles |
What to do — step by step
Check Product Details
Identify the bottle count and lot number on the packaging to confirm if it matches the recalled items.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Are there specific lot numbers that are affected?
Yes, affected lot numbers include JKP3150B (expiring 06/17), JKP2757A (expiring 05/17), and others as listed in the recall.
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Other Sun Pharmaceutical recalls
Keep exploring
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-0700-2017 (March 22, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0700-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.