Ascend Laboratories Cephalexin for Oral Suspension Recall

Why it was recalled

CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.

Product description

Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88

Lot numbers, UPCs & expiration codes

Lot # 19144841, Exp 9/2021; 20141673 Exp 4/2022.

Where it was sold

Nationwide in the USA

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0263-2021
Classification: Class II
Status: Terminated
Recall initiated: Jan 22, 2021
FDA report date: Feb 24, 2021
Quantity: 14,205 100 mL bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Ascend Laboratories LLC

Original FDA data

Every field from FDA enforcement report D-0263-2021, exactly as published.

Show all FDA fields

City: Parsippany
State: NJ
Status: Terminated
Country: United States
Event ID: 87214
Address: 339 Jefferson Rd Ste 101
Code information: Lot # 19144841, Exp 9/2021; 20141673 Exp 4/2022.
Postal code: 07054-3707
Report date: Feb 24, 2021
Product type: Drugs
Recall number: D-0263-2021
Classification: Class II
Recalling firm: Ascend Laboratories LLC
Product quantity: 14,205 100 mL bottles
Termination date: Dec 2, 2022
Reason for recall: CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88
Distribution pattern: Nationwide in the USA
Recall initiation date: Jan 22, 2021
Initial firm notification: E-Mail
Center classification date: Feb 18, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0263-2021, published Feb 24, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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