FDA Recall D-0646-2024

Dr. Reddy's Laboratories, Inc. · Princeton, NJ

Class II Ongoing 646 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tablets per bottle.

Lot / code: a)NDC 55111-682-01 Lots C2207529, Exp 5/31/2026; C2210993, Exp 9/30/2026. b)NDC 55111-682-05 Lots C2207530, Exp 5/31/2026; C2210992, C2210994, Exp 9/30/2026; C2213304, C2213305, Exp 11/30/2026.

Quantity: 14940 bottles

Reason for recall

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

Recall record

Recall number: D-0646-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Distribution: Nationwide in the USA and Puerto Rico
Recall initiated: 2024-08-06
Classified by FDA Center: 2024-08-26
FDA published: 2024-09-04
Recalling firm: Dr. Reddy's Laboratories, Inc.
Firm location: Princeton, NJ

Drug identification

Brand name(s): IBU
Generic name(s): IBUPROFEN
Manufacturer(s): Dr. Reddy's Laboratories Limited
NDC(s): 55111-682, 55111-683, 55111-684
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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