CLASS II Drug recall · Reported 25 Sep 2013 · FDA Enforcement Report
IBU (TM) Ibuprofen Tablets, USP, 800 mg recalled
Dr. Reddy's Laboratories is recalling IBU (TM) Ibuprofen Tablets, USP, 800 mg,(, distributed nationwide in the US. The recall was initiated on 29 Aug 2013 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-1042-2013
- FDA event ID
- 66117
- Recalling firm
- Dr. Reddy's Laboratories, Bridgewater, NJ
- Brand
- Ibu
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Aug 2013
- FDA classified
- 13 Sep 2013
- Reported
- 25 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 29 Aug 2013 | Recall initiated by company | |
| 13 Sep 2013 | Classified by FDA | +15 days |
| 25 Sep 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.
Product as listed by the FDA
IBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only, Distributed by Dr. Reddy's Laboratories, Inc., Bridgewater, NJ 08807 USA.
Where it was distributed
Nationwide (& Puerto Rico)
Questions about this recall
Is IBU (TM) Ibuprofen Tablets, USP, 800 mg,( recalled?
Yes. Dr. Reddy's Laboratories recalled IBU (TM) Ibuprofen Tablets, USP, 800 mg,( on 29 Aug 2013. The recall is Class II and its status is Terminated. Recall number D-1042-2013.
Why was it recalled?
Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.
Which lots are affected?
Lot # L300192; Exp. 05/2017
Where was it sold?
Nationwide (& 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 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 Ibuprofen recalls
All 38| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Children's Ibuprofen Oral Suspension, USP, 100 mg recalledIbuprofen | Strides Pharma | Particulate Matter | Nationwide |
| Drug | CLASS III | IBU (ibuprofen) recalled by Dr. Reddy's LaboratoriesIbu | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS II | IBU Ibuprofen Tablets, USP, 600 mg recalled by Dr. Reddy's LaboratoriesIbu | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | IBU Ibuprofen Tablets, USP, 400 mg recalled by Dr. Reddy's LaboratoriesIbu | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size recalled | Preferred Pharmaceuticals | Potency & Assay | CA, NV |