CLASS II Drug recall · Reported 28 Nov 2018 · FDA Enforcement Report
Clopidogrel Tablets, USP, 300 mg, 30 ( unit-dose) count recalled
Dr. Reddy's Laboratories is recalling Clopidogrel Tablets, USP, 300 mg, 30 ( unit-dose) count, distributed nationwide in the US. The recall was initiated on 7 Nov 2018 and the FDA has classified it as Class II.
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-0283-2019
- FDA event ID
- 81530
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Manufacturer
- Dr.Reddy's Laboratories Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Nov 2018
- FDA classified
- 27 Nov 2018
- Reported
- 28 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Thinners
Timeline
| 7 Nov 2018 | Recall initiated by company | |
| 27 Nov 2018 | Classified by FDA | +20 days |
| 28 Nov 2018 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
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
Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31
Where it was distributed
U.S.A.nationwide
Questions about this recall
Is Clopidogrel Tablets, USP, 300 mg, 30 ( unit-dose) count recalled?
Yes. Dr. Reddy's Laboratories recalled Clopidogrel Tablets, USP, 300 mg, 30 ( unit-dose) count on 7 Nov 2018. The recall is Class II and its status is Terminated. Recall number D-0283-2019.
Why was it recalled?
Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
Which lots are affected?
Lot #: T600530, Exp 11/18
Where was it sold?
U.S.A.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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 Clopidogrel Bi recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clopidogrel Tablets, USP, 300 mg, 30 ( unit-dose) count recalledClopidogrel Bisulfate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |