Medications & Supplements/Prescription Drugs

Direct Rx Ibuprofen 800mg Tablets Recalled for Failed Impurity Specifications

Agency Publication Date: November 7, 2024

Summary

Direct Rx has issued a voluntary recall for 1,410 bottles of Ibuprofen 800mg tablets (generic for Motrin), manufactured by Dr. Reddy's Laboratories. The recall was initiated because the product failed impurity and degradation specifications during 18-month stability testing. Affected bottles include 15, 30, 40, 60, 90, 100, and 120-count containers with various expiration dates through March 2027. Consumers who have the affected medication should stop using it and consult their pharmacist or healthcare provider.

Risk

The product failed impurity testing, which means the active ingredient or chemical components may have degraded over time beyond safe or effective levels. Using degraded medication can result in reduced effectiveness of the treatment or exposure to unexpected chemical byproducts.

What You Should Do

This recall involves Ibuprofen 800mg tablets, a generic version of Motrin, packaged by Direct Rx in various bottle sizes ranging from 15-count to 120-count.
Identify your product by checking the NDC code and lot number printed on the bottle label. Affected NDC codes include 61919-0621-15, 61919-0621-30, 61919-0621-40, 61919-0621-60, 61919-0621-90, 61919-0621-100, 61919-0621-71, and 61919-0621-72. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Ibuprofen 800mg Tablets

Variants: 800 mg, Tablet, Generic for Motrin

Lot Numbers:

02FE2414 (Exp 11/30/26)

18JU2407 (Exp 11/30/26)

27JY2316 (Exp 02/28/27)

13SE2317 (Exp 03/31/27)

13OC2312 (Exp 03/31/27)

23AU2307 (Exp 03/31/27)

25SE2308 (Exp 03/31/27)

29MA2313 (Exp 12/31/26)

23MA2315 (Exp 12/31/26)

25MY2304 (Exp 01/31/27)

26JU2313 (Exp 02/28/27)

27JY2314 (Exp 02/28/27)

27SE2322 (Exp 03/31/27)

30OC2304 (Exp 03/31/27)

12OC2301 (Exp 03/31/27)

11SE2322 (Exp 11/30/26)

02FE2419 (Exp 11/30/26)

23JA2405 (Exp 11/30/26)

10JA2426 (Exp 11/30/26)

17MY2416 (Exp 11/30/26)

05DE2312 (Exp 11/30/26)

24OC2321 (Exp 11/30/26)

05FE2433 (Exp 11/30/26)

20MA2418 (Exp 11/30/26)

29NO2317 (Exp 11/30/26)

31MA2308 (Exp 12/31/26)

25SE2305 (Exp 03/31/27)

NDC:

61919-0621-15

61919-0621-30

61919-0621-40

61919-0621-60

61919-0621-90

61919-0621-100

61919-0621-71

61919-0621-72

Packaged and Distributed by: DIRECT Rx, Dawsonville, GA. Manufactured By: Dr. Reddy's Laboratories LA, LLC.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95618

Status: Active

Manufacturer: Direct Rx

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 1410 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves Ibuprofen 800mg tablets, a generic version of Motrin, packaged by Direct Rx in various bottle sizes ranging from 15-count to 120-count.

Identify your product by checking the NDC code and lot number printed on the bottle label. Affected NDC codes include 61919-0621-15, 61919-0621-30, 61919-0621-40, 61919-0621-60, 61919-0621-90, 61919-0621-100, 61919-0621-71, and 61919-0621-72. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Ibuprofen 800mg Tablets

Variants: 800 mg, Tablet, Generic for Motrin

Lot Numbers:

02FE2414 (Exp 11/30/26)

18JU2407 (Exp 11/30/26)

27JY2316 (Exp 02/28/27)

13SE2317 (Exp 03/31/27)

13OC2312 (Exp 03/31/27)

23AU2307 (Exp 03/31/27)

25SE2308 (Exp 03/31/27)

29MA2313 (Exp 12/31/26)

23MA2315 (Exp 12/31/26)

25MY2304 (Exp 01/31/27)

26JU2313 (Exp 02/28/27)

27JY2314 (Exp 02/28/27)

27SE2322 (Exp 03/31/27)

30OC2304 (Exp 03/31/27)

12OC2301 (Exp 03/31/27)

11SE2322 (Exp 11/30/26)

02FE2419 (Exp 11/30/26)

23JA2405 (Exp 11/30/26)

10JA2426 (Exp 11/30/26)

17MY2416 (Exp 11/30/26)

05DE2312 (Exp 11/30/26)

24OC2321 (Exp 11/30/26)

05FE2433 (Exp 11/30/26)

20MA2418 (Exp 11/30/26)

29NO2317 (Exp 11/30/26)

31MA2308 (Exp 12/31/26)

25SE2305 (Exp 03/31/27)

NDC:

61919-0621-15

61919-0621-30

61919-0621-40

61919-0621-60

61919-0621-90

61919-0621-100

61919-0621-71

61919-0621-72

Packaged and Distributed by: DIRECT Rx, Dawsonville, GA. Manufactured By: Dr. Reddy's Laboratories LA, LLC.