Recalls / Class II
Class IID-0644-2024
Product
IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tablets per bottle.
- Brand name
- Ibu
- Generic name
- Ibuprofen
- Active ingredient
- Ibuprofen
- Route
- Oral
- NDCs
- 55111-682, 55111-683, 55111-684
- FDA application
- ANDA075682
- Affected lot / code info
- a) NDC 55111-684-01 Lots C2207525, Exp 5/31/2026; C2212902, Exp 11/30/2026. b) NDC 55111-684-05 Lots C2207526, Exp 5/31/2026; C2210751, C2210752, Exp 9/30/2026; C2212765, C2212766, Exp 11/30/2026; C2301027, C2301063, C2301187, C2301188, C2301247, Exp 12/31/2026; C2301356, C2301388, C2301494, C2301478, C2301617, Exp 1/31/2027; C2303381, C2303432, C2303565, C2303630, C2303643, C2303710, Exp 2/28/2027; C2303879, C2303806, C2303895, C2303963, C2304263, C2304264, C2304130, C2304163, C2304427, Exp 3/31/2027.
Why it was recalled
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 103,298 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2024-08-06
- FDA classified
- 2024-08-26
- Posted by FDA
- 2024-09-04
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0644-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.