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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Cephalexin Oral Suspension Recalled for Labeling Errors

Agency Publication Date: June 4, 2024
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Summary

Bryant Ranch Prepack, Inc. is recalling approximately 517 bottles of Cephalexin for Oral Suspension, USP (generic Keflex) because of significant errors on the labels. Some labels incorrectly state the medication contains "Tablets" instead of liquid suspension, while others list the wrong total dosage of the antibiotic per bottle. This recall affects five different configurations of the medication with various lot numbers and expiration dates through 2025.

Risk

Incorrect dosage and unit information on drug labels can lead to confusion and measurement errors, potentially causing patients to receive the wrong amount of medication.

What You Should Do

  1. This recall affects multiple versions of Cephalexin for Oral Suspension, USP, relabeled by Bryant Ranch Prepack, Inc. with NDC codes 63629-9204-1, 63629-9205-1, 63629-8858-1, 63629-9206-1, and 63629-9207-1.
  2. Check the bottle label for the NDC code and lot number printed on the package. See the Affected Products section below for the full list of affected codes.
  3. 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.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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: Cephalexin for Oral Suspension, USP, 125mg per 5mL (100mL)
Variants: 125mg per 5mL, Oral Suspension
Lot Numbers:
225541 (Exp: 03/31/2025)
226866 (Exp: 03/31/2025)
227369 (Exp: 03/31/2025)
227519 (Exp: 03/31/2025)
229845 (Exp: 03/31/2025)
231422 (Exp: 03/31/2025)
234889 (Exp: 03/31/2025)
NDC:
63629-9204-1

Front label states 100 Tablets instead of 100 ml; back label says Each Tablet contains instead of Each Bottle contains.

Product: Cephalexin for Oral Suspension, USP, 125mg per 5mL (200mL)
Variants: 125mg per 5mL, Oral Suspension, Strawberry flavored
Lot Numbers:
234892 (Exp: 02/28/2025)
NDC:
63629-9205-1

Back label states equivalent to 2.5g instead of 5g.

Product: Cephalexin for Oral Suspension, USP, 250mg per 5mL (200mL mixed)
Variants: 250mg per 5mL, Oral Suspension
Lot Numbers:
235287 (Exp: 12/31/2025)
235629 (Exp: 12/31/2025)
235805 (Exp: 12/31/2025)
236292 (Exp: 12/31/2025)
237022 (Exp: 12/31/2025)
237308 (Exp: 12/31/2025)
237748 (Exp: 12/31/2025)
NDC:
63629-8858-1

Back label states equivalent to 5g instead of 10g.

Product: Cephalexin for Oral Suspension, USP, 250mg per 5mL (100mL mixed)
Variants: 250mg per 5mL, Oral Suspension
Lot Numbers:
235288 (Exp: 11/30/2025)
235294 (Exp: 11/30/2025)
235368 (Exp: 11/30/2025)
235806 (Exp: 11/30/2025)
236058 (Exp: 11/30/2025)
236138 (Exp: 11/30/2025)
236139 (Exp: 11/30/2025)
236351 (Exp: 11/30/2025)
236490 (Exp: 11/30/2025)
236757 (Exp: 11/30/2025)
236877 (Exp: 11/30/2025)
236758 (Exp: 12/31/2025)
236762 (Exp: 12/31/2025)
237254 (Exp: 12/31/2025)
237349 (Exp: 12/31/2025)
237401 (Exp: 12/31/2025)
237807 (Exp: 12/31/2025)
NDC:
63629-9206-1

Back label states 'Each contains' instead of 'Each Bottle contains'.

Product: Cephalexin for Oral Suspension, USP, 250mg/5mL (200mL mixed)
Variants: 250mg per 5mL, Oral Suspension
Lot Numbers:
235067 (Exp: 12/31/2025)
235289 (Exp: 11/30/2025)
235290 (Exp: 12/31/2025)
NDC:
63629-9207-1

Back label states equivalent to 5g instead of 10g.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94605
Status: Active
Manufacturer: Bryant Ranch Prepack, Inc.
Manufactured In: United States
Units Affected: 5 products (156 bottles; 6 bottles; 104 bottles; 190 bottles; 61 Bottles)
Distributed To: Nationwide

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 ยท 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.