Class II · Moderate risk
Children's Ibuprofen Oral Suspension
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
IBU (ibuprofen)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Tablet/Capsule Specifications
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05
Affected NDC
55111-0683-05
Compare with the code on your package — it is the most precise check available.
Drug: Ibuprofen Category: Pain Relief & OTC Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Ibu Ibuprofen NDC 55111-0683 |
600 mg/1 | Tablet Oral |
Dr. Reddy's Laboratories Limited | Rx |
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- NDC code
- 55111-683-05
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0047-2025 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Ibuprofen recalls
See all
Class II · Moderate risk
Advil a) Ibuprofen
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Acetaminophen and Ibuprofen
CGMP Deviations
Class II · Moderate risk
Ibuprofen 800mg
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Class II · Moderate risk
Ibuprofen Tablets
Failed Impurities/Degradation Specifications - at 18-month Stability testing
Other recalls by Dr. Reddy's Laboratories, Inc.
All 2024 recalls
Class III · Low risk
Varenicline Tablets
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Class II · Moderate risk
Succinylcholine Chloride Injection
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Class II · Moderate risk
Omeprazole Delayed-release Capsules
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Class I · High risk
Levetiracetam 0.75% in Sodium Chloride Injection 1
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
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