Propranolol Hydrochloride Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Most common reason: Labeling / mix-up (7 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Propranolol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
Failed Tablet/Capsule Specification: Teva is recalling certain lots of Propanolol HCl Tablets, 10 mg due to the potential of some tablets not conforming to weight specification.
Labeling: Label Mixup: PROPRANOLOL HCL, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: LORazepam, Tablet, 0.25 mg (1/2 of 0.5 mg), NDC 00591024001, Pedigree: AD60243_1, EXP: 5/22/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011001, Pedigree: W003068, EXP: 6/12/2014.
Labeling: Label Mixup: PROPRANOLOL HCL ER, Capsule, 60 mg may have potentially been mislabeled as the following drug: CINACALCET HCL, Tablet, 30 mg, NDC 55513007330, Pedigree: AD52778_82, EXP: 5/21/2014.
Labeling: Label Mixup; PROPRANOLOL HCL Tablet, 80 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD42584_12, EXP: 5/14/2014.
Labeling: Label Mixup; PROPRANOLOL HCL Tablet, 10 mg may be potentially mislabeled as LACTOBACILLUS ACIDOPHILUS, Capsule, NDC 54629011101, Pedigree: AD65311_4, EXP: 5/24/2014.
Labeling: Label Mixup; PROPRANOLOL HCL Tablet, 5 mg (1/2 of 10 mg) may be potentially mislabeled as LITHIUM CARBONATE ER, Tablet, 225 mg (1/2 of 450 mg), NDC 00054002025, Pedigree: AD73525_16, EXP: 5/30/2014.
Labeling: Label Mixup; PROPRANOLOL HCL, Tablet, 10 mg may be potentially mislabeled as PERPHENAZINE, Tablet, 16 mg, NDC 00781104901, Pedigree: AD21790_31, EXP: 5/1/2014; buPROPion HCl ER (XL), Tablet, 150 mg, NDC 67767014130, Pedigree: AD52412_4, EXP: 4/30/2014; MULTIVITAMIN/MULTIMINERAL LOW IRON, Tablet, NDC 64376081601, Pedigree: AD60272_31, EXP: 5/22/2014; PERPHENAZINE, Tablet, 16 mg, NDC
Labeling: Label Mixup; PROPRANOLOL HCL, Tablet, 10 mg may be potentially mislabeled as PIOGLITAZONE HCL, Tablet, 15 mg, NDC 00093204856, Pedigree: AD52778_70, EXP: 5/21/2014.
Failed Dissolution Test Requirements
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