CLASS III Drug recall · Reported 17 May 2017 · FDA Enforcement Report
Olanzapine Tablets, 5 mg recalled by Sun Pharmaceutical Industries
Sun Pharmaceutical Industries is recalling Olanzapine Tablets, 5 mg, distributed nationwide in the US. The recall was initiated on 22 Mar 2017 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0700-2017
- FDA event ID
- 76819
- Recalling firm
- Sun Pharmaceutical Industries, Cranbury, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 Mar 2017
- FDA classified
- 10 May 2017
- Reported
- 17 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 22 Mar 2017 | Recall initiated by company | |
| 10 May 2017 | Classified by FDA | +49 days |
| 17 May 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Is Olanzapine Tablets, 5 mg recalled?
Yes. Sun Pharmaceutical Industries recalled Olanzapine Tablets, 5 mg on 22 Mar 2017. The recall is Class III and its status is Terminated. Recall number D-0700-2017.
Why was it recalled?
Failed Impurities/Degradation Specifications: out of specification results for the related substances test parameter (impurities).
Which lots are affected?
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
Where was it sold?
Nationwide in the USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Sun Pharmaceutical Industries
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|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Perampanel CIII Tablets, 6mg recalled by Sun Pharmaceutical IndustriesPerampanel | Sun Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | Sun Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension, 1mg recalledBudesonide | Sun Pharmaceutical Industries | Particulate Matter | Nationwide |
Other Olanzapine recalls
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Olanzapine Tablets, USP 5 mg recalled by Macleods PharmaceuticalsOlanzapine | Macleods Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Olanzapine Orally Disintegrating Tablets recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Olanzapine Tablets, USP 10 mg recalled by Macleods Pharma UsaOlanzapine | Macleods Pharma Usa | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Olanzapine Orally Disintegrating Tablets, 5 mg ( unit dose) recalled | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Olanzapine Tablets, USP 5 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Potency & Assay | Nationwide |