Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured ...

FDA Drug Recall #D-0468-2025 — Class II — May 23, 2025

Recall Summary

Recall Number D-0468-2025
Classification Class II — Moderate risk
Date Initiated May 23, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ascend Laboratories, LLC
Location Parsippany, NJ
Product Type Drugs
Quantity 48,936 - 100 mL bottles

Product Description

Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-88

Reason for Recall

Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.

Distribution Pattern

Nationwide in the USA.

Lot / Code Information

Lot #: 23141828, 23141829, Exp Date: 5/31/2025; 23142342, Exp Date: 6/30/2025; 23142708, Exp Date: 7/31/2025; 23144035, Exp Date: 10/31/2025; 23144270, Exp Date: 11/302025; 24140026, Exp Date: 12/31/2025

Other Recalls from Ascend Laboratories, LLC

Recall # Classification Product Date
D-0019-2026 Class II Atorvastatin Calcium Tablets USP, 20 mg, Rx Onl... Sep 19, 2025
D-0020-2026 Class II Atorvastatin Calcium Tablets USP, 80 mg, Rx Onl... Sep 19, 2025
D-0017-2026 Class II Atorvastatin Calcium Tablets USP, 10 mg, Rx Onl... Sep 19, 2025
D-0018-2026 Class II Atorvastatin Calcium Tablets USP, 40 mg, Rx Onl... Sep 19, 2025
D-0645-2025 Class II Aripiprazole Tablets, USP, 10 mg, 30-count bott... Aug 28, 2025

Frequently Asked Questions

Nitrosamines are probable human carcinogens — they can increase cancer risk with long-term exposure above certain thresholds, but they do not cause immediate harm from taking a single dose. The FDA calculates an acceptable daily intake (ADI) for each nitrosamine compound, and recalls are triggered when levels exceed this threshold. If you have been taking a recalled product, the FDA generally advises against abruptly stopping your medication (especially for critical conditions like blood pressure or diabetes) until you consult your doctor. The incremental cancer risk from short-term exposure is very small.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.