Propranolol Hydrochloride 20 mg Tablets Recalled for Temperature Storage Deviations
Propranolol Hydrochloride tablets have been recalled nationwide. Products were exposed to temperatures outside labeled storage conditions during manufacturing, potentially affecting drug stability.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall involves a CGMP deviation regarding storage temperature conditions. No illnesses or injuries have been reported. The hazard involves potential compromise of drug stability rather than contamination or acute safety risk, consistent with a Moderate severity classification.
Plain-English summary
Cardinal Healthcare is recalling Propranolol Hydrochloride Tablets 20 mg manufactured by Amneal Pharmaceuticals Pvt. Ltd. in India and distributed nationwide in the United States. The recalled batch is 100023596.
The recall was initiated due to CGMP (Current Good Manufacturing Practice) deviations. Specifically, products were exposed to temperatures outside the range specified on the product label during manufacturing and storage. This improper temperature exposure could potentially affect the medication's stability and effectiveness.
Patients currently taking Propranolol Hydrochloride should consult their pharmacist or healthcare provider to determine if they have the affected product. Patients should not stop taking their medication without consulting their healthcare provider, as discontinuation without medical guidance could have adverse health consequences.
The recalled product
- Product
- PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL HYDROCHLORIDE)
- Brand
- PROPRANOLOL HYDROCHLORIDE
- Manufacturer
- CARDINAL HEALTHCARE
- Hazard
- improper-storage
- stability-concern
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch 100023596
UPCs (5)
- 0369238208016
- 0369238207712
- 0369238208115
- 0369238207910
- 0369238207811
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27