Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250 mg/5mL, ...

FDA Drug Recall #D-0342-2021 — Class II — April 12, 2021

Recall Summary

Recall Number D-0342-2021
Classification Class II — Moderate risk
Date Initiated April 12, 2021
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Preferred Pharmaceuticals, Inc.
Location Anaheim, CA
Product Type Drugs
Quantity Six bottles

Product Description

Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250 mg/5mL, Pkg Size 100, Rx only, Repackaged by Preferred Pharmaceuticals, Inc., Mfg: Ascend Laboratories, LLC, NDC #: 68788-7529-1,

Reason for Recall

Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin

Distribution Pattern

recalled product was distributed to three physicians located CA

Lot / Code Information

Lot #: B1121W, Exp.Date: 04/2022

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D-0647-2024 Class II Ibuprofen Tablets, USP 400mg, Generic for Motri... Aug 8, 2024
D-0505-2024 Class II Duloxetine Delayed-Release Cap USP 30mg, 30-cou... May 10, 2024
D-0894-2023 Class II Tizanidine Hydrochloride Tablet 4mg, packaged i... Jun 26, 2023

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.