Cephalexin for Oral Suspension recall
FDA recall D-0537-2024 · initiated May 10, 2024
Bryant Ranch Prepack, Inc. recalled Cephalexin for Oral Suspension in May 2024 — an FDA Class III recall (D-0537-2024) because Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 6 bottles
Details
- Product
- Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate, USP equivalent to 2.5g of cephalexin in a strawberry flavored mixture. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9205-1.
- Recalling company
- Bryant Ranch Prepack, Inc.
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- May 10, 2024
- FDA report date
- Jun 12, 2024
Frequently asked
- Was Cephalexin for Oral Suspension recalled?
- Bryant Ranch Prepack, Inc. recalled Cephalexin for Oral Suspension in May 2024 — an FDA Class III recall (D-0537-2024) because Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Cephalexin for Oral Suspension recalled?
- Per the FDA enforcement record, the reason for recall D-0537-2024 was: Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
- Is a recalled Cephalexin for Oral Suspension dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Cephalexin for Oral Suspension are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot:234892, Exp:02/28/2025.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0537-2024.