CLASS II ONGOING Drug recall · Reported 4 Sep 2024 · FDA Enforcement Report

IBU Ibuprofen Tablets, USP, 600 mg recalled by Dr. Reddy's Laboratories

Dr. Reddy's Laboratories is recalling IBU Ibuprofen Tablets, USP, 600 mg, distributed nationwide in the US. The recall was initiated on 6 Aug 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa)NDC 55111-683-01 Lots C2207527, Exp 5/31/2026; C2210864, Exp 9/30/2026; C2213018, Exp 11/30/2026. b)NDC 5511-683-05 Lots C2207528, Exp 5/31/2026; C2210860, Exp 9/30/2026; C2213016, C2213017, Exp 11/30/2026; C2301852, C2302056, C2302057, Exp 1/31/2027.

NDC55111-682, 55111-683, 55111-684

Quantity recalled31,802 bottles

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-0645-2024
FDA event ID: 95098
Recalling firm: Dr. Reddy's Laboratories, Princeton, NJ
Brand: Ibu
Manufacturer: Dr. Reddy's Laboratories Limited
Classification: Class II
Status: Ongoing
Recall initiated: 6 Aug 2024
FDA classified: 26 Aug 2024
Reported: 4 Sep 2024
Type: Voluntary: Firm initiated
Reason category: Potency & Assay
Drug class: Pain Medication

Timeline

6 Aug 2024	Recall initiated by company
26 Aug 2024	Classified by FDA	+20 days
4 Sep 2024	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

Nationwide in the USA and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Is IBU Ibuprofen Tablets, USP, 600 mg recalled?

Yes. Dr. Reddy's Laboratories recalled IBU Ibuprofen Tablets, USP, 600 mg on 6 Aug 2024. The recall is Class II and its status is Ongoing. Recall number D-0645-2024.

Why was it recalled?

Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.

Which lots are affected?

a)NDC 55111-683-01 Lots C2207527, Exp 5/31/2026; C2210864, Exp 9/30/2026; C2213018, Exp 11/30/2026. b)NDC 5511-683-05 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 was it sold?

Nationwide in the USA and 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

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Other Ibuprofen recalls

All 38

Reported	Class	Recall	Company	Reason	Where
25 Mar 2026Drug	CLASS II	Children's Ibuprofen Oral Suspension, USP, 100 mg recalledIbuprofen	Strides Pharma	Particulate Matter	Nationwide
27 Nov 2024Drug	CLASS III	IBU (ibuprofen) recalled by Dr. Reddy's LaboratoriesIbu	Dr. Reddy's Laboratories	Other	Nationwide
4 Sep 2024Drug	CLASS II	IBU Ibuprofen Tablets, USP, 400 mg recalled by Dr. Reddy's LaboratoriesIbu	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
4 Sep 2024Drug	CLASS II	Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size recalled	Preferred Pharmaceuticals	Potency & Assay	CA, NV
4 Sep 2024Drug	CLASS II	IBU Ibuprofen Tablets, USP, 800 mg recalled by Dr. Reddy's LaboratoriesIbu	Dr. Reddy's Laboratories	Potency & Assay	Nationwide