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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 C2207525, Exp 5/31/2026; C2212902, Exp 11/30/2026. b) NDC [redacted-phone] 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.
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

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Brand nameIBU
Generic nameIBUPROFEN
Active ingredient(s)IBUPROFEN
Distributed by / forDr. Reddy's Laboratories, Inc.
NDC55111-684-01
Show the full FDA record
Full product labelIBU 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.
Recalling firmDr. Reddy's Laboratories, Inc.
DistributionNationwide in the USA and Puerto Rico
Quantity103,298 bottles
Recall initiated2024-08-06
Report date2024-09-04
Recall completed—
Recall numberD-0644-2024
ClassificationClass II
FDA statusOngoing
Origin on filePrinceton NJ United States

Related

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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.