Dr. Reddy's Laboratories, Inc. recalls
88 recalls in our records from 2012 to 2025: 88 FDA drugs.
Recalls with full detail pages
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Dr. Reddy's Laboratories, Inc. drug recall: Levetiracetam 0.75% in Sodium Chloride Injection 1
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging…
Earlier and other recalls
These link to the official agency notice.
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Dr. Reddy's Laboratories, Inc. drug recall: Varenicline Tablets Official notice ↗
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
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Dr. Reddy's Laboratories, Inc. drug recall: Succinylcholine Chloride Injection Official notice ↗
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
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Dr. Reddy's Laboratories, Inc. drug recall: Omeprazole Delayed-release Capsules Official notice ↗
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
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Dr. Reddy's Laboratories, Inc. drug recall: Javygtor Official notice ↗
Failed Impurities/Degradation Specifications
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Dr. Reddy's Laboratories, Inc. drug recall: Ibu Official notice ↗
Failed Tablet/Capsule Specifications
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Dr. Reddy's Laboratories, Inc. drug recall: Morphine Sulfate Extended-Release Tablets 15 mg Official notice ↗
Failed Impurities/Degradation Specification
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Dr. Reddy's Laboratories, Inc. drug recall: Cinacalcet Tablets Official notice ↗
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
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Dr. Reddy's Laboratories, Inc. drug recall: IBU Ibuprofen Tablets Official notice ↗
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
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Dr. Reddy's Laboratories, Inc. drug recall: Sevelamer Carbonate for Oral Suspension 0.8g packets Official notice ↗
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
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Dr. Reddy's Laboratories, Inc. drug recall: Allopurinol Tablets Official notice ↗
Presence of foreign substance.
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Dr. Reddy's Laboratories, Inc. drug recall: Eszopiclone Tablets Official notice ↗
Failed Impurities/Degradation Specifications: Related Substances
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Dr. Reddy's Laboratories, Inc. drug recall: Zoledronic Acid Injection 5mg/100mL Sterile Solution Official notice ↗
Lack of Assurance of Sterility: Leaking vials
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Dr. Reddy's Laboratories, Inc. drug recall: Sirolimus Tablets 1mg Tablets 100-count bottle Official notice ↗
Failed Impurities/Degradation Specifications
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Dr. Reddy's Laboratories, Inc. drug recall: Javygtor Official notice ↗
Sub-potent Drug; powder discoloration associated with decreased potency
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Dr. Reddy's Laboratories, Inc. drug recall: Glimepiride Tablets Official notice ↗
Misprint on tablet
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Dr. Reddy's Laboratories, Inc. drug recall: Tizanidine Tablets Official notice ↗
Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
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Dr. Reddy's Laboratories, Inc. drug recall: Tacrolimus Capsules Official notice ↗
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
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Dr. Reddy's Laboratories, Inc. drug recall: Montelukast Sodium Tablets Official notice ↗
Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
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Dr Reddy's Laboratories Limited drug recall: Tizanidine Tablets USP Official notice ↗
Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
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Dr. Reddy's Laboratories, Inc. drug recall: Tacrolimus Capsules Official notice ↗
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
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Dr. Reddy's Laboratories, Inc. drug recall: Allergy Relief D Official notice ↗
Failed dissolution specifications
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Dr. Reddy's Laboratories, Inc. drug recall: Phytonadione Injectable Emulsion USP Official notice ↗
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
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Dr. Reddy's Laboratories, Inc. drug recall: Lansoprazole Delayed-Release Orally Disintegrating Tablets Official notice ↗
FAILED DISSOLUTION SPECIFICATIONS
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Dr. Reddy's Laboratories, Inc. drug recall: Lansoprazole Delayed-Release Orally Disintegrating Tablets Official notice ↗
Failed Dissolution Specifications
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Dr. Reddy's Laboratories, Inc. drug recall: Lansoprazole Delayed-Release Capsules Official notice ↗
Failed Dissolution Specifications; during long term stability testing.
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Dr. Reddy's Laboratories, Inc. drug recall: Atorvstatin Calcium Tablets Official notice ↗
Failed Impurities/Degradation Specifications: Out of Specification results for related substance.
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Dr. Reddy's Laboratories, Inc. drug recall: Sapropterin Dihydrochloride Powder for Oral Solution Official notice ↗
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
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Dr. Reddy's Laboratories, Inc. drug recall: Azacitidine Official notice ↗
Failed stability specifications
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Dr. Reddy's Laboratories, Inc. drug recall: Mucus Relief D Official notice ↗
Subpotent drug
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Dr. Reddy's Laboratories, Inc. drug recall: Wal-Fex D Official notice ↗
Failed Dissolution Specifications
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Dr. Reddy's Laboratories, Inc. drug recall: Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120… Official notice ↗
Failed dissolution specifications
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Dr. Reddy's Laboratories, Inc. drug recall: Dr. Reddy's Ezetimibe and Simvastatin Tablets Official notice ↗
Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
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Dr. Reddy's Laboratories, Inc. drug recall: Omeprazole Delayed-Release Capsules Official notice ↗
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
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Dr. Reddy's Laboratories, Inc. drug recall: Tizanidine HCl Tablets Official notice ↗
Failed Tablet/Capsule Specification: Some tablets are shaved
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Dr. Reddy's Laboratories, Inc. drug recall: Atorvastatin Calcium Tablets Official notice ↗
Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
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Dr. Reddy's Laboratories, Inc. drug recall: Atorvastatin Calcium Tablets Official notice ↗
Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
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Dr. Reddy's Laboratories, Inc. drug recall: Progesterone Capsules Official notice ↗
Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
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Dr. Reddy's Laboratories, Inc. drug recall: Atorvastatin Calcium Tablets Official notice ↗
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
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Dr. Reddy's Laboratories, Inc. drug recall: Imatinib Mesylate Tablets 100mg Official notice ↗
Failed Dissolution Specifications
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Dr. Reddy's Laboratories, Inc. drug recall: Esomeprazole Magnesium Delayed Release Capsules USP Official notice ↗
Discoloration: product contains brown pellets
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Dr. Reddy's Laboratories, Inc. drug recall: Phytonadione Injectable Emulsion Official notice ↗
Defective Container: Recall is due to breaking and shattering of ampules upon opening
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Dr. Reddy's Laboratories, Inc. drug recall: Dr. Reddy's: Ranitidine Capsules 150 mg Official notice ↗
CGMP Deviations: Presence of NDMA impurity detected in product.
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Dr. Reddy's Laboratories, Inc. drug recall: Divalproex Sodium Extended-Release Tablets Official notice ↗
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
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Dr. Reddy's Laboratories, Inc. drug recall: Docetaxel Injection USP Official notice ↗
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
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Dr. Reddy's Laboratories, Inc. drug recall: Divalproex Sodium Extended-release Tablets Official notice ↗
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
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Dr. Reddy's Laboratories, Inc. drug recall: Esomeprazole Magnesium Delayed-Release Capsules USP Official notice ↗
Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
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Dr. Reddy's Laboratories, Inc. drug recall: Levetiracetam in 0.54 % Sodium Chloride Injection 1 Official notice ↗
Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75%…
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Dr. Reddy's Laboratories, Inc. drug recall: Ezetimibe and Simvastatin Tablets 10mg/80 mg Official notice ↗
Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
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Dr. Reddy's Laboratories, Inc. drug recall: Clopidogrel Tablets Official notice ↗
Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.
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Dr. Reddy's Laboratories, Inc. drug recall: Clopidogrel Tablets Official notice ↗
Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.
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Dr. Reddy's Laboratories, Inc. drug recall: Nystatin and Triamcinolone Acetonide Cream Official notice ↗
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
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Dr. Reddy's Laboratories, Inc. drug recall: Zoledronic Acid Injection Official notice ↗
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
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Dr. Reddy's Laboratories, Inc. drug recall: Tizanidine HCl Tablets Official notice ↗
Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
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Dr. Reddy's Laboratories, Inc. drug recall: Atorvastatin Calcium tablets Official notice ↗
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in…
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Dr. Reddy's Laboratories, Inc. drug recall: Atorvastatin Calcium Tablets Official notice ↗
Failed Impurities/Degradation Specifications
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Dr. Reddy's Laboratories, Inc. drug recall: Atorvastatin Calcium Tablets Official notice ↗
Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.
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Dr. Reddy's Laboratories, Inc. drug recall: Metoprolol Succinate Extended-Release Tablets Official notice ↗
Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante Extended-Release Tablets.
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Dr. Reddy's Laboratories, Inc. drug recall: Clocortolone Pivalate Cream Official notice ↗
Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
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Dr. Reddy's Laboratories, Inc. drug recall: Atorvastatin Calcium Tablets 10 mg Official notice ↗
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
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Dr. Reddy's Laboratories, Inc. drug recall: Docetaxel Injection USP Official notice ↗
Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is…
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Dr. Reddy's Laboratories, Inc. drug recall: Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol Official notice ↗
Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle
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Dr. Reddy's Laboratories, Inc. drug recall: Famotidine tablets Official notice ↗
Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing…
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Dr. Reddy's Laboratories, Inc. drug recall: Pravastatin Sodium Tablets Official notice ↗
Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
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Dr. Reddy's Laboratories, Inc. drug recall: Zenatane Official notice ↗
Failed Dissolution Specifications: out of specification results observed for low dissolution.
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Dr. Reddy's Laboratories, Inc. drug recall: RIVASTIGMINE Tartrate Capsules Official notice ↗
Cross-contamination with other products -Related Substances test for Rivastigmine Tartrate Capsules USP, 1.5 mg showed a peak for Ranitidine.
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Dr. Reddy's Laboratories, Inc. drug recall: Zenatane Official notice ↗
Failed dissolution specifications - low dissolution results at S3 stage.
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Dr. Reddy's Laboratories, Inc. drug recall: Olanzapine tablets Official notice ↗
Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability…
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Dr. Reddy's Laboratories, Inc. drug recall: Flucanozole Tablets Official notice ↗
Failed Dissolution Specifications; 18 month stability time point
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Dr. Reddy's Laboratories, Inc. drug recall: Zenatane Official notice ↗
Failed Dissolution Specifications
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Dr. Reddy's Laboratories, Inc. drug recall: Sirolimus Tablets Official notice ↗
Failed impurities/degradation: out of specification result for impurity secorapamycin.
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Dr. Reddy's Laboratories, Inc. drug recall: CVS pharmacy Original Strength Acid Controller tablets Official notice ↗
Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th…
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Dr. Reddy's Laboratories, Inc. drug recall: Ondansetron Tablets USP Official notice ↗
Failed Impurities/Degradation Specifications; 12 month stability time point
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Dr. Reddy's Laboratories, Inc. drug recall: Zoledronic Acid Injection Official notice ↗
Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tightly to the vial
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Dr. Reddy's Laboratories, Inc. drug recall: Paricalcitol Capsules Official notice ↗
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
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Dr. Reddy's Laboratories, Inc. drug recall: Amlodipine besylate and Atorvastatin calcium Tablets Official notice ↗
Subpotent Drug: Subpotent atorvastatin.
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Dr. Reddy's Laboratories, Inc. drug recall: Rivastigmine Tartrate Capsules Official notice ↗
Failed Dissolution Specifications
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Dr. Reddy's Laboratories, Inc. drug recall: Amlodipine besylate and Atorvastatin calcium tablets Official notice ↗
Subpotent drug
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Dr. Reddy's Laboratories, Inc. drug recall: Divalproex Sodium Extended-Release Tablets Official notice ↗
Failed Dissolution Specifications; exceeded specification at the 9 hour time point
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Dr. Reddy's Laboratories, Inc. drug recall: Dr. Reddy's Metoprolol Succinate Extended Release Tablets Official notice ↗
Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.
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Dr. Reddy's Laboratories, Inc. drug recall: a) Walgreens Lansoprazole Delayed Release Capsules Official notice ↗
Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole…
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Dr. Reddy's Laboratories, Inc. drug recall: Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP Official notice ↗
Failed Dissolution Specification; 12-Month stability interval.
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Dr. Reddy's Laboratories, Inc. drug recall: Ibu Official notice ↗
Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.
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Dr. Reddy's Laboratories, Inc. drug recall: Ranitidine Hydrochloride Tablets Official notice ↗
Microbial Contamination of Non-Sterile Products: A lot of raw material used in the manufacture of Ranitidine was positive for Pseudomonas sp.
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Dr. Reddy'S Laboratories drug recall: Tizanidine Tablets USP Official notice ↗
Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.
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Dr. Reddy's Laboratories, Inc. drug recall: Citalopram tablets USP Official notice ↗
Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.
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Dr. Reddy's Laboratories, Inc. drug recall: Dr. Reddy's Quetiapine Fumarate Tablets Official notice ↗
Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25…
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Dr. Reddy's Laboratories, Inc. drug recall: Dr. Reddy's Amlodipine Besylate and Benazepril Hydrochloride 5 mg*/20… Official notice ↗
Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride…
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.