Recent Drug Recalls: Lisdexamfetamine, Duloxetine, Omeprazole, Budesonide, Timolol Maleate, Clomipramine, Cinacalcet

(August 10, 2025)

Drug Recall: Duloxetine Tablets (Cymbalta generic) by Breckenridge

Breckenridge is recalling more than 12,000 30-count bottles of duloxetine delayed release, 40mg tablets due to the presence of nitrosamine impurities above FDA recommended limit. Nitrosamine impurities can increase risk of cancer. The drug is manufactured by Towa Pharmaceuticals in Barcelona, Spain. Duloxetine is generic for Cymbalta and treats depression. The FDA classified the recall as class II on July 30, 2025. Breckenridge issued a larger recall,, for over 343,000 bottles, for other lots and strengths of this drug April 2025. Check the enforcement report for specific lot numbers and expiration dates.
Recall Announcement

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Drug Recall: Rizatriptan Tablets by Ascend

Ascend Laboratories is recalling 5mg and 10mg strength rizatriptan tablets due to the presence of nitrosamine impurities. Nitrosamine impurities can increase risk of cancer. The quantity is not listed in the recall announcement. The drug is manufactured in India by Alkem Laboratories Ltd. Rizatriptan is generic for migraine headache drug Maxalt. The FDA classified the recall as class II on July 17, 2025.
Recall Announcement

Drug Recall: Lisdexamfetamine (Vyvanse generic) Capsules by Sun Pharma

Sun Pharmaceuticals is recalling 5,488 bottles of 100-count lisdexamfetamine dimesylate 60 mg capsules due to “failed dissolution specifications,” or problems with long-term (9 month) stability. The capsules are manufactured in New Brunswick, NJ by OHM Labs for distribution by Sun Pharma. The recalled units were sent to 17 distributors who may have further distributed the product nationwide. Lisdexamfetamine is a stimulant and also sold as an ADHD treatment under the brand names Vyvanse and Elvanse. The recall was initiated on June 16 and classified as a Class II recall on July 11, 2025. Lisdexamfetamine comes in strength from 10 mg to 60 mg.

Note: FDA and an investigative report by Propublica have found violations at Sun Pharma’s Indian-based facilities recently. This facility for lisdexamfetamine is in the U.S. Recall Lisdexamfetamine capsules from Sun Pharma

Recall Announcement (enforcement report)
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Drug Recall: Budesonide by Cipla

Cipla USA is recalling 13,680 ampoules of budesonide (an asthma treatment) due to lack of assurance of sterility. Some complaints have been received for leaky and/or empty ampoules.  The medication is manufactured in Pithampur, Idia by Cipla Ltd. Recall Initiation Date was June 30, 2025 and the FDA classified it as a Class II recall on July 22, 2025. This medication is administered by administered via jet nebulizer. Budesonide is generic for Pulmicort.
Recall Announcement


Drug Recall: Omeprazole by Dr. Reddy's

Dr. Reddy’s Laboratories is recalling 1,476 bottles of its omeprazole delayed-release capsules due to the “presence of foreign tablets/capsules” within the Omeprazole bottles. Divalproex Sodium extended-release 250 mg tablets were found mixed in with the Omeprazole capsules. The capsules are manufactured at Dr. Reddy’s Bachupally India plant. The recall was initiated June 30, 2025 and classified as a Class 2 Recall on July 14, 2025. Omeprazole is used to treat acid reflux,GERD, and ulcers.
Recall Announcement

 

Drug Recall: Timolol Maleate Ophthalmic Eye Drops by FDC Ltd. (Rising Sun Pharma) and Apotex

FDC Limited is recalling 154,176 5 ml bottles and more than 60,428 10 ml bottles of .5% timolol maleate Ophthalmic eye drops made by FDC Limited in Aurangabad, Maharashtra, India due to a detective cap and container. The spike of the cap may be lodged in the nozzle of the product bottle. This medication is used to treat glaucoma. It is distributed by Rising Sun Pharmaceuticals. The recall was initiated in April and June and July 2025 and classified as a class II recall.
 Timolol maleate drops recall

Recall Announcement (for the 154K recall); and Recall Announcement for the 60K recall

Read or add reviews for Timolol Maleate.

Apotex is recalling more than 6,000 bottles of Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL  The drops are manufactured by: Apotex Inc., Toronto, Ontario, Canada due to lack of sterility. Classified as Class II recall on June 25, 2025.
Recall Announcement for Apotex


Drug Recall: Clomipramine Hydrochloride by Lupin

Lupin Pharmaceuticals Inc. is recalling 2,724 bottles of 100-count clomipramine hydrochloride Capsules due to a failed degradation product test near the product expiration date. It is not known where the medication was manufactured. The recall was initiated on June 27 and classified by the fda on 7/21/2025. Clomipramine is a dibenzazepine drug also known as tricyclic antidepressant and is often used to treat obsessive-compulsive-disorder (OCD). Its brand name is Anafranil.
Recall Announcement

Drug Recall: Cinacalcet Tablets by Stride Pharma

Strides Pharma is recalling 6,200 bottles of 30-count 90 mg cinacalcet tablets due to failed dissolution specifications. This means that the drug may not be absorbed in the body enough to be effective. Cinacalcet is the generic version of Sensipar, a treatment for secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis The product is manufactured by Strides Pharma Science Limited in Puducherry, India. The recall was classified as a Class II recall on July 30, 2025.
Recall Announcement

Note: product images are from the National Library of Medicine's DailyMed database. Recall information is linked and is from FDA Enforcement Reports.

Check out our other recent list of recalls, including Sucralfate, Levothyroxine, and Gabapentin.