Cephalosporin Antibacterial
Where is Cephalexin made?
21 companies sell it under their own name and 38 repackagers rebottle it. Their labels name 5 factories in India and Taiwan.
India 3Taiwan 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| American Health Packaging250 mg, 500 mg · NDC 60687-152, 60687-163 | Alkem Laboratories LimitedMakes it | Amaliya Daman, India | No problems foundAug 2019 |
| Ascend Laboratories, LLC125 mg per 5 mL, 250 mg, 250 mg per 5 mL, 333 mg, 500 mg, 750 mg · NDC 67877-544, 67877-220, 67877-891 +5 | Alkem Laboratories LimitedMakes it | Amaliya Daman, India | No problems foundAug 2019 |
| Aurobindo Pharma Limited125 mg per 5 mL, 250 mg, 250 mg per 5 mL, 500 mg, 750 mg · NDC 59651-322, 59651-783, 65862-018 +4 | Aurobindo Pharma LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilySep 2023 |
| Belcher Pharmaceuticals,LLC250 mg, 500 mg · NDC 62250-801, 62250-802 | Belcher Pharmaceuticals, LLCMakes it and tests it | Location not on file | Not inspected on record |
| Cronus Pharma LLC250 mg, 500 mg · NDC 69043-008, 69043-009 | Aurobindo Pharma LimitedMakes it and tests it | Sangareddy, India | Problems found, fixed voluntarilySep 2023 |
| Lupin Pharmaceuticals, Inc.125 mg per 5 mL, 250 mg, 250 mg per 5 mL, 500 mg · NDC 68180-123, 68180-440, 68180-121 +3 | Lupin LimitedMakes it, makes the active ingredient and packages it | Mandideep, India | Serious problems, FDA actionNov 2022 |
| Major Pharmaceuticals250 mg, 500 mg · NDC 0904-7336, 0904-7337 | Alkem Laboratories LimitedMakes it, tests it and packages it | Amaliya Daman, India | No problems foundAug 2019 |
| OrchidPharma Inc125 mg per 5 mL, 250 mg per 5 mL · NDC 59834-202, 59834-203 | Hospira Healthcare India Pvt LtdMakes it, tests it, packages it and labels it | Location not on file | Not inspected on record |
| Pharma-C, Inc.250 mg, 500 mg · NDC 69778-930, 69778-931 | Yung Shin Pharm. Ind. Co., Ltd. (taichung Youth Factory)Makes it, packages it and labels it | Taichung City, Taiwan | Problems found, fixed voluntarilyOct 2019 |
| TWi Pharmaceuticals, Inc.125 mg per 5 mL, 250 mg per 5 mL · NDC 24979-154, 24979-155 | Yung Shin Pharm. Ind. Co., Ltd.Makes it, tests it and packages it | Taichung City, Taiwan | Problems found, fixed voluntarilyOct 2019 |
| Amella Pharma, LLC500 mg · NDC 72287-310 | The label doesn't name the factory. Plants this company names for other drugs | ||
| American Antibiotics, Inc250 mg, 500 mg · NDC 15749-801, 15749-802 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AvKARE, Inc.250 mg, 500 mg · NDC 42291-006, 42291-208, 42291-007 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AvPAK250 mg, 500 mg · NDC 50268-151, 50268-152 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Bi-Coastal Pharma International LLC250 mg, 500 mg · NDC 42582-211, 42582-212 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Carlsbad Technology, Inc.125 mg per 5 mL, 250 mg per 5 mL · NDC 61442-201, 61442-202 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.125 mg per 5 mL, 250 mg, 250 mg per 5 mL, 500 mg · NDC 62135-480, 62135-710, 62135-481 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Jazeera Pharmaceutical125 mg per 5 mL, 250 mg per 5 mL · NDC 68289-008, 68289-009 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Ranbaxy Laboratories Inc.125 mg per 5 mL, 250 mg, 250 mg per 5 mL, 500 mg · NDC 63304-958, 63304-656, 63304-959 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sun Pharmaceutical Industries Limited250 mg, 500 mg · NDC 62756-293, 62756-294 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.125 mg per 5 mL, 250 mg, 250 mg per 5 mL, 500 mg · NDC 0093-4175, 0093-2238, 0093-3145 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Cephalexin in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-0071,50090-0070,50090-3291,50090-3202+20 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0005,80425-0121,80425-0004,80425-0006 - Aidarex Pharmaceuticals LLC:
33261-149,53217-299,33261-485,33261-020+1 - Altura Pharmaceuticals, Inc.:
63874-111,63874-112 - Apotheca, Inc.:
12634-434 - Asclemed USA, Inc.:
76420-034,76420-287,76420-594,76420-754+7 - Blenheim Pharmacal, Inc.:
10544-021,10544-868,10544-142,10544-946+12 - Brisk Pharmaceuticals, Inc.:
73614-202 - Bryant Ranch Prepack:
72162-1850,63629-9204,63629-9205,63629-4222+38 - Central Texas Community Health Centers:
76413-142 - Coupler LLC:
67046-1533,67046-1120,67046-1245 - Denton Pharma, Inc. DBA Northwind Pharmaceuticals.:
70934-108,70934-840,70934-109,70934-065 - Direct Rx:
61919-049,61919-029,61919-522,61919-358+4 - Dispensing Solutions Inc.:
66336-055 - H.J. Harkins Co., Inc.:
52959-030,52959-620,52959-031 - Hawaii Repack, Inc.:
85534-0076,85534-0077,85534-0078,85534-0079 - Liberty Pharmaceuticals, Inc.:
0440-1243,0440-7244 - MedVantx, Inc.:
66116-607,66116-255,66116-388,66116-398+1 - Medsource Pharmaceuticals:
45865-428 - Northwind Pharmaceuticals:
82868-057,82868-095 - NuCare Pharmaceuticals.Inc.:
68071-2246,68071-4516,68071-4465,68071-5241+16 - PD-Rx Pharmaceuticals, Inc.:
43063-678,43063-497,55289-057,72789-252+4 - Physicians Total Care, Inc.:
54868-0538,54868-0153,54868-1385,54868-0154 - Preferred Pharmaceuticals, Inc..:
68788-7796,68788-9713,68788-4167,68788-7529+6 - Proficient Rx LP:
63187-205,71205-553,71205-591,63187-046+2 - QPharma, Inc.:
42708-100,42708-145,42708-070,42708-017 - RPK Pharmaceuticals, Inc.:
53002-2260,53002-2261,53002-2540,53002-2181+2 - ReadyMeds:
64205-101,64205-102 - Rebel Distributors Corp..:
21695-789,42254-338,21695-316,42254-197+3 - RedPharm Drug. Inc.:
67296-1362,67296-0320,67296-1211,67296-1292+3 - Remedyrepack Inc.:
70518-2273,70518-4250,70518-4511,70518-3378+5 - Sportpharm LLC:
85766-005,85766-004,85766-191 - Stat Rx USA:
16590-466,16590-050,16590-049,16590-051+1 - State of Florida DOH Central Pharmacy:
53808-0222,53808-0622,53808-0939 - Strategic Pharmaceutical Solutions, Inc. DBA VetSource:
49364-110,49364-111 - TYA Pharmaceuticals:
64725-0101,64725-0121,64725-1021 - Unit Dose Services:
50436-7216,50436-0117,50436-1020,50436-2210+1 - Unit Dose Solutions, Inc.:
87441-004
Recalls
- May 23, 2025 · Class II · Ascend Laboratories, LLC · 2 recall notices
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. - May 10, 2024 · Class III · Bryant Ranch Prepack, Inc.
Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g' - May 10, 2024 · Class III · Bryant Ranch Prepack, Inc. · 2 recall notices
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g' - May 10, 2024 · Class III · Bryant Ranch Prepack, Inc.
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 - May 10, 2024 · Class III · Bryant Ranch Prepack, Inc.
Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g' - Apr 12, 2021 · Class II · Preferred Pharmaceuticals, Inc.
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 - Jan 22, 2021 · Class II · Ascend Laboratories LLC · 2 recall notices
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit. - Dec 17, 2020 · Class II · Ascend Laboratories LLC · 2 recall notices
Failed Impurity/Degradation Specifications - Nov 23, 2020 · Class II · Ascend Laboratories LLC
Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL. - Aug 24, 2020 · Class II · Teva Pharmaceuticals USA · 2 recall notices
CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits. - Aug 24, 2020 · Class II · Teva Pharmaceuticals USA
Sub-Potent Drug: Out of specification test results for potency (below specification). - Jan 9, 2019 · Class II · Lupin Pharmaceuticals Inc.
CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.