Breckenridge Pharmaceutical, Inc. recalls
Every recall we track for Breckenridge Pharmaceutical, Inc. — 35 in all, from 2015–2026 — plus the complaints and injury reports the public filed about them. 3 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Breckenridge Pharmaceutical, Inc. peaked in 2025 (13); 34 since 2017. 6% rated “stop using now”.
All FDA recall records for Breckenridge Pharmaceutical, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 1 | 1 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 2 | 3 |
| 2021 | 0 | 0 | 0 | 1 | 1 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 5 | 1 | 6 |
| 2024 | 0 | 0 | 2 | 5 | 7 |
| 2025 | 1 | 1 | 2 | 9 | 13 |
| 2026 (to date) | 0 | 0 | 0 | 3 | 3 |
Breckenridge Pharmaceutical, Inc. recalls before 2017
Recalls on record by year.
Most common reasons for Breckenridge Pharmaceutical, Inc. recalls
What to do if you have a recalled Breckenridge Pharmaceutical, Inc. product
- Match the NDC and lot number on your bottle or box to the recall.
- Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
- Report side effects to FDA MedWatch.
All Breckenridge Pharmaceutical, Inc. recalls
21 shown- UnratedDrug
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules
Breckenridge Pharmaceutical recalls 60mg Duloxetine Delayed-Release Capsules due to N-nitroso-duloxetine impurity exceeding FDA limits. Rx-only medication with specific lot numbers and expiration dates.
BreckenridgeJun 4, 2026 - UnratedDrug
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L.,
Breckenridge Pharmaceutical recalls 60mg Duloxetine capsules due to N-nitroso-duloxetine impurity exceeding FDA limits. Affected lots: 241069C (exp 05/31/2027).
Breckenridge PharmaceuticalApr 21, 2026 - UnratedDrug
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals
Breckenridge Pharmaceutical recalls 60mg Duloxetine Delayed-Release Capsules due to N-nitroso-duloxetine impurity exceeding FDA limits. Affected lots manufactured in Spain, distributed in the US. Consumers should contact for remedy.
BreckenridgeNov 24, 2025 - UnratedDrug
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC
Breckenridge Pharmaceutical recalls 60mg Duloxetine Delayed-Release Capsules due to N-nitroso-duloxetine impurity exceeding safety limits. Affected products include 90-count (NDC 51991-748-90) and 1000-count (NDC 51991-748-10) bottles. No remedy specified in recall notice.
Breckenridge PharmaceuticalOct 9, 2025 - UnratedDrug
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa
Breckenridge Pharmaceutical recalls 30mg Duloxetine capsules due to N-nitroso-duloxetine impurity exceeding safety limits. Affected lots manufactured in Spain for US distribution.
BreckenridgeAug 8, 2025 - UnratedDrug
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa
Breckenridge Pharmaceutical recalls 60mg Duloxetine Delayed-Release Capsules due to potential N-nitroso-duloxetine impurity above FDA limits. Affected lots: NDC 82009-032-10, Lot 240539C (expiring 1/31/2027).
BreckenridgeJul 25, 2025 - UnratedDrug
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L.
Breckenridge Pharmaceuticals recalls 60mg Duloxetine Delayed-Release Capsules due to N-nitroso-duloxetine impurity exceeding safety limits. Affected lots manufactured in Spain, distributed in the US. No specific remedy stated in official notice.
BreckenridgeJul 15, 2025 - Lower riskDrug
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L.
Breckenridge Pharmaceuticals recalls 40mg Duloxetine capsules due to potential N-nitroso impurity above FDA limits. Affected lots may pose health risks; contact for details.
BreckenridgeJun 30, 2025 - Use cautionDrug
Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical
Breckenridge recalls 16,473 bottles of Duloxetine 60 mg capsules due to CGMP deviations and nitrosamine impurity above interim limits.
Breckenridge PharmaceuticalApr 14, 2025 - UnratedDrug
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa
Breckenridge Pharmaceutical recalls 30mg Duloxetine capsules due to potential nitrosamine impurity. Affected lots may pose health risks; contact for return instructions.
BreckenridgeMar 26, 2025 - UnratedDrug
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L.
Breckenridge recalls 20mg Duloxetine capsules with N-nitroso impurity above FDA limits. Stop using if you have affected lots. Details: NDC 51991-746-05, Lot 240098C.
BreckenridgeFeb 28, 2025 - Lower riskDrug
Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa
Breckenridge recalls 30mg Duloxetine capsules (NDC 51991-747-90) due to N-nitroso-duloxetine impurity exceeding FDA limits. Affected lots may pose health risks.
BreckenridgeDec 6, 2024 - UnratedDrug
Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L.
Breckenridge Pharmaceutical recalls 20mg Duloxetine capsules due to potential N-nitroso impurity exceeding FDA safety limits. Affected lots may pose health risks.
BreckenridgeOct 10, 2024 - UnratedDrug
Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L.
Breckenridge Pharmaceutical recalls 60mg Duloxetine capsules due to potential N-nitroso impurity above FDA limits. Affected lots: 230035C (exp 11/30/2025) and 230101C (exp 12/31/2025).
BreckenridgeMay 17, 2024 - UnratedDrug
Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L.
Breckenridge Pharmaceutical recalls 60mg Duloxetine capsules due to potential N-nitroso impurity exceeding FDA limits. Affected bottles have specific NDC codes and expiration dates. Consumers should contact the company for details.
BreckenridgeApr 29, 2024 - Lower riskDrug
Breckenridge Pharmaceutical, Inc recalls Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC
Breckenridge Pharmaceutical recalls 1mg Alprazolam tablets (NDC 51991-0706-01, 05, 10) due to potential cross contamination. Rx only, manufactured in India. Check lot numbers for affected batches.
BreckenridgeMar 2, 2023 - UnratedDrug
Breckenridge Pharmaceutical, Inc recalls Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge
Breckenridge Pharmaceutical recalls 20mg Omeprazole Delayed-Release Capsules due to stability testing showing unknown impurities. This may affect drug safety for patients using prescription medication.
BreckenridgeMar 11, 2021 - Stop using nowDrug
Breckenridge Pharmaceutical, Inc recalls Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single
Breckenridge Pharmaceutical recalls Zoledronic Acid Injection 5 mg/100 mL due to impurities found in stability testing. This may cause serious injury if used. Contact for return instructions.
BreckenridgeFeb 24, 2020 - UnratedDrug
Breckenridge Pharmaceutical, Inc recalls Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51991-894-33) and b) 90-count bottles (NDC
Breckenridge Pharmaceutical recalls 10mg Solifenacin Succinate tablets due to manufacturing error that may convert to a different, potentially harmful form. Affected products have specific NDC numbers and expiration dates.
BreckenridgeJan 24, 2020 - UnratedDrug
Breckenridge Pharmaceutical, Inc. recalls Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical,
Breckenridge Pharmaceutical recalls Megestrol Acetate Oral Suspension (625 mg/5mL) due to failed stability testing. This prescription drug may have particle size issues affecting safety.
Breckenridge PharmaceuticalNov 6, 2018 - Stop using nowDrug
Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve,
Breckenridge recalls Duloxetine 60mg capsules due to a foreign omeprazole capsule. Check lot 142391, exp 10/2016.
Breckenridge PharmaceuticalOct 21, 2015
Breckenridge Pharmaceutical, Inc. recall questions
How many recalls has Breckenridge Pharmaceutical, Inc. had?
35 recalls from Breckenridge Pharmaceutical, Inc. are on record with U.S. safety agencies, from 2015–2026.
What is the most recent Breckenridge Pharmaceutical, Inc. recall?
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules, dated Jun 4, 2026. Every Breckenridge Pharmaceutical, Inc. recall is listed on this page, newest first.
Why are Breckenridge Pharmaceutical, Inc. products recalled?
The most common reasons on record: CGMP Deviations: Potential risk of Cross Contamination (6).
What should I do if I have a recalled Breckenridge Pharmaceutical, Inc. product?
Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.
How do I get alerts for new Breckenridge Pharmaceutical, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.