CLASS III Drug recall · Reported 12 Apr 2017 · FDA Enforcement Report
Rivastigmine Tartrate Capsules, USP, 5 mg recalled
Dr. Reddy's Laboratories is recalling Rivastigmine Tartrate Capsules, USP, 5 mg, distributed nationwide in the US. The recall was initiated on 6 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-0649-2017
- FDA event ID
- 76699
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Mar 2017
- FDA classified
- 6 Apr 2017
- Reported
- 12 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 6 Mar 2017 | Recall initiated by company | |
| 6 Apr 2017 | Classified by FDA | +31 days |
| 12 Apr 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.
Product as listed by the FDA
RIVASTIGMINE Tartrate Capsules, USP, 1.5 mg, 60-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally 500-900 India, NDC 55111-352-60
Where it was distributed
U.S. nationwide
Questions about this recall
Is Rivastigmine Tartrate Capsules, USP, 5 mg recalled?
Yes. Dr. Reddy's Laboratories recalled Rivastigmine Tartrate Capsules, USP, 5 mg on 6 Mar 2017. The recall is Class III and its status is Terminated. Recall number D-0649-2017.
Why was it recalled?
Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.
Which lots are affected?
Lot #C607323, Exp 10/18
Where was it sold?
U.S. nationwide
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 Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
Other Rivastigmine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Rivastigmine Tartrate Capsules, USP 5 mg recalledRivastigmine Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |