Teva Pharmaceuticals USA recalls Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle
Teva Pharmaceuticals USA recalls specific lots of Cephalexin oral suspension due to potential active ingredient levels outside specifications. Consumers should check their product details and contact the company for guidance.
Lower-risk recall
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.
Contact the company & request your remedy
What happened, in plain English
Teva Pharmaceuticals is recalling certain lots of Cephalexin oral suspension (250 mg per 5 mL) because some bottles may have incorrect active ingredient levels. This could lead to improper dosing if the medication is not within the specified concentration range. Read more at govinfonow.com/recall/36823-teva-cephalexin-oral-suspension-recall-possible-incorrect-dosage-levels.
Source Summary by GovInfoNow · govinfonow.com/recall/36823-teva-cephalexin-oral-suspension-recall-possible-incorrect-dosage-levels · Updated October 4, 2026 · FDA enforcement record: FDA #D-0013-2021
Cite this page
“Teva Cephalexin Oral Suspension Recall: Possible Incorrect Dosage Levels.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36823-teva-cephalexin-oral-suspension-recall-possible-incorrect-dosage-levels. Based on FDA recall #D-0013-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0013-2021%22&limit=1).
Why it’s dangerous
The recall is due to CGMP deviations where some bottles may have the active ingredient above or below the specified concentration limits. This could result in incorrect dosing if the medication is not within the intended concentration range.
Who’s affected
Patients prescribed Cephalexin by a doctor who own or use the recalled lots of 100 mL or 200 mL bottles. Those with specific lot numbers and expiration dates listed in the recall are most at risk.
How to tell if you have this one
Check for the product name 'Cephalexin for Oral Suspension, USP 250 mg per 5 mL' on the label. Look for the lot numbers and expiration dates listed in the recall details (e.g., lot 30309862A, exp. 08/2020).
- Brand
Teva Pharmaceuticals- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in the U.S. and Puerto Rico.- NDC
0093-3145-01, 0093-3145-05, 0093-3147-01, 0093-3147-05, 0093-4175-73, 0093-4175-74, 0093-4177-73, 0093-4177-74
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0012-2021 | Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4175-73, b) 200 mL bottle when mixed, NDC 0093-4175-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.; Lot #s: a) 30309820A, Exp. 08/2020; 30310000B, 30310001B, Exp. 10/2020; 30310096A Exp. 01/2021; 30310228A, Exp. 03/2021; 30310313A, Exp. 06/2021; b) 30309861A, Exp. 08/2020; 30310335A, Exp. 06/2021. | 103,940 bottles |
| D-0013-2021 | Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4177-73, b) 200 mL bottle when mixed, NDC 0093-4177-74, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.; Lot #s: a) 30309862A, 30309863A, Exp. 08/2020; 30309928A, 30309929A, Exp. 09/2020; 30310029A, 30310030A, 30310033A, 30310034A, Exp. 10/2020; 30310035A, 30310079A, 30310080A, 30310081A, Exp. 11/2020; 30310134A, 30310135A, Exp. 01/2021; 30310182A, 30310183A, 30310210A, Exp. 02/2021; 30310211A, 30310246A, Exp. 03/2021; 30310282A, Exp. 04/2021; 30310290A, Exp. 05/2021; 30310394A, 30310395A, Exp.07/2021; 30310457A, Exp. 09/2021; 30310506A, 30310507A, Exp. 10/2021; 30310555A, 30310605A, Exp. 11/2021. b) 30309864A, 30309865A, Exp. 08/2020; 30309930A, 30309931A, Exp. 09/2020; 30309991A, 30309992A, 30310028A, Exp.10/2020; 30310036A, 30310037A, 30310038A, Exp. 11/2020; 30310082A, 30310083A, Exp. 12/2020; 30310136A, 30310137A, Exp. 01/2021; 30310184A, 30310185A, Exp. 02/2021; 30310212A, Exp. 03/2021; 30310303A, Exp. 04/2021; 30310327A, Exp. 06/2021; 30310396A, 30310407A, Exp. 08/2021; 30310445A, Exp. 09/2021; 30310556A, Exp. 10/2021. | 1,467,535 bottles |
| D-1566-2020 | Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, 100 mL bottle when mixed, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4177-73.; Lot #: 30310638A, Exp. 02/2022 | 38,487 bottles |
What to do — step by step
Check Product Details
Identify the product by checking the label for the specific lot numbers and expiration dates listed in the recall.
Questions people ask
Why is this medication being recalled?
The recall is due to CGMP deviations where some bottles may have the active ingredient above or below the specified concentration limits.
How can I tell if I have a recalled product?
Check the label for the product name 'Cephalexin for Oral Suspension, USP 250 mg per 5 mL' and verify the lot numbers and expiration dates listed in the recall details.
What should I do if I have a recalled product?
The recall does not specify a remedy, so contact Teva Pharmaceuticals USA for guidance on next steps.
Contact Teva Pharmaceuticals
We’ve drafted a message you can send Teva Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0013-2021 — Teva Pharmaceuticals Teva Pharmaceuticals Hello, I own a Teva Pharmaceuticals that is covered by recall D-0013-2021 from Teva Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0013-2021 (August 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0013-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.