Dr. Reddy's Laboratories, Inc. 2024-09-04 Health serious FDA
Health · FDA · Recall #FDA-D-0644-2024
IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc.,… Recall
Issued September 4, 2024 · Dr. Reddy's Laboratories, Inc.
In September 2024, Dr. Reddy's Laboratories, Inc. recalled the IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc.,…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
What you should do
- 1 Stop using IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc.,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Dr. Reddy's Laboratories, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Dr. Reddy's Laboratories, Inc.
- Category
- Health
- Recall date
- September 4, 2024
- Units affected
- Not reported
- Sold at
- Nationwide in the USA and Puerto Rico
- Recall number
- FDA-D-0644-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Dr. Reddy's Laboratories, Inc. has 17 recalls in our database, including 3 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.