Class II · ModerateActive recall
Ibu
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numbera)NDC [redacted-phone] Lots C2207527, Exp 5/31/2026; C2210864, Exp 9/30/2026; C2213018, Exp 11/30/2026. b)NDC [redacted-phone] Lots C2207528, Exp 5/31/2026; C2210860, Exp 9/30/2026; C2213016, C2213017, Exp 11/30/2026; C2301852, C2302056, C2302057, Exp 1/31/2027.
Where it was soldNationwide in the USA and Puerto Rico
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byMade in India foreign manufacturer
| Brand name | IBU |
| Generic name | IBUPROFEN |
| Active ingredient(s) | IBUPROFEN |
| Distributed by / for | Dr. Reddy's Laboratories, Inc. |
| NDC | 55111-683-01 |
Show the full FDA record
| Full product label | IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 - 100 Tablets per bottle, b)NDC 5511-683-05 - 500 Tablets per bottle. |
| Recalling firm | Dr. Reddy's Laboratories, Inc. |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 31,802 bottles |
| Recall initiated | 2024-08-06 |
| Report date | 2024-09-04 |
| Recall completed | — |
| Recall number | D-0645-2024 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Princeton NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.