CLASS III Drug recall · Reported 10 Mar 2021 · FDA Enforcement Report

Atorvastatin Calcium Tablets, 40mg recalled by Dr. Reddy's Laboratories

Dr. Reddy's Laboratories is recalling Atorvastatin Calcium Tablets, 40mg, distributed nationwide in the US. The recall was initiated on 19 Feb 2021 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesa) T900406, exp 3/2021 b) T000078 exp 12/2021 T000079 exp 12/2021 T000080 exp 12/2021 T000081 exp 12/2021 T000082 exp 12/2021 T000083 exp 12/2021 T000084 exp 12/2021 T000085 exp 12/2021 T000086 exp 12/2021 T000087 exp 12/2021 T000088 exp 1/2022 T000311 exp 1/2022 T000312 exp 1/2022 T000313 exp 1/2022 T000314 exp 1/2022 T000315 exp 1/2022 T000316 exp 1/2022 T000317 exp 1/2022 T000318 exp 1/2022 T000319 exp 1/2022 T000320 exp 1/2022 T000500 exp 2/2022 T000501 exp 2/2022 T000502 exp 2/2022 T000503 exp 2/2022 T000504 exp 2/2022 T000505 exp 2/2022 T000506 exp 2/2022 T000507 exp 2/2022 T000508 exp 2/2022 T000509 exp 3/2022 T000510 exp 3/2022 T000647 exp 3/2022 T000648 exp 3/2022 T000651exp 3/2022 T000652 exp 3/2022 T000653 exp 3/2022 T000654 exp 3/2022 T000875 exp 4/2022 T000876 exp 4/2022 T000877 exp 4/2022 T000878 exp 4/2022 T000879 exp 4/2022 T000880 exp 4/2022 T000881 exp 4/2022 T000882 exp 4/2022 T000883 exp 4/2022 T000884 exp 4/2022 T001120 exp 5/2022 T001121 exp 5/2022 T001122 exp 5/2022 T001124 exp 5/2022 T001125 exp 5/2022 T001126 exp 5/2022 T001127 exp 5/2022 T001128 exp 5/2022 T001129 exp 5/2022 T001130 exp 5/2022 T001260 exp 5/2022 T001261 exp 5/2022 T900506 exp 4/2021 T900507 exp 4/2021 T900508 exp 4/2021 T900655 exp 5/2021 T900656 exp 5/2021 T900657 exp 5/2021 T900658 exp 5/2021 T900659 exp 5/2021 T900673 exp 5/2021 T900674 exp 5/2021 T901024 exp 7/2021 T901025 exp 7/2021 T901026 exp 7/2021 T901027 exp 7/2021 T901029 exp 7/2021 T901030 exp 7/2021 T901031 exp 7/2021 T901032 exp 7/2021 T901033 exp 7/2021 T901424 exp 10/2021 T901425 exp 10/2021 T901426 exp 10/2021 T901427 exp 10/2021 T901428 exp 10/2021 T901429 exp 10/2021 T901430 exp 10/2021 T901431 exp 10/2021 T901432 exp 10/2021 T901433 exp 10/2021 T901568 exp 10/2021 T901569 exp 10/2021 T901570 exp 11/2021 T901571 exp 11/2021 T901572 exp 11/2021 T901573 exp 11/2021 T901574 exp 11/2021 T901575 exp 11/2021 T901576 exp 11/2021 T901577 exp 11/2021

NDC55111-121, 55111-122, 55111-123

UPC0355111123903

Quantity recalled10,440 90-count and 224,710 500-count bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0291-2021
FDA event ID: 87365
Recalling firm: Dr. Reddy's Laboratories, Princeton, NJ
Brand: Atorvastatin Calcium
Manufacturer: Dr. Reddy's Laboratories Limited
Classification: Class III
Status: Terminated
Recall initiated: 19 Feb 2021
FDA classified: 1 Mar 2021
Reported: 10 Mar 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Cholesterol Medication

Timeline

19 Feb 2021	Recall initiated by company
1 Mar 2021	Classified by FDA	+10 days
10 Mar 2021	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA

Where it was distributed

Distributed Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities

Which lots are affected?

a) T900406, exp 3/2021 b) T000078 exp 12/2021 T000079 exp 12/2021 T000080 exp 12/2021 T000081 exp 12/2021 T000082 exp 12/2021 T000083 exp 12/2021 T000084 exp 12/2021 T000085 exp 12/2021 T000086 exp 12/2021 T000087 exp 12/2021 T000088 exp 1/2022 T000311 exp 1/2022 T000312 exp 1/2022 T000313 exp 1/2022 T000314 exp 1/2022 T000315 exp 1/2022 T000316 exp 1/2022 T000317 exp 1/2022 T000318 exp 1/2022 T000319 exp 1/2022 T000320 exp 1/2022 T000500 exp 2/2022 T000501 exp 2/2022 T000502 exp 2/2022 T000503 exp 2/2022 T000504 exp 2/2022 T000505 exp 2/2022 T000506 exp 2/2022 T000507 exp 2/2022 T000508 exp 2/2022 T000509 exp 3/2022 T000510 exp 3/2022 T000647 exp 3/2022 T000648 exp 3/2022 T000651exp 3/2022 T000652 exp 3/2022 T000653 exp 3/2022 T000654 exp 3/2022 T000875 exp 4/2022 T000876 exp 4/2022 T000877 exp 4/2022 T000878 exp 4/2022 T000879 exp 4/2022 T000880 exp 4/2022 T000881 exp 4/2022 T000882 exp 4/2022 T000883 exp 4/2022 T000884 exp 4/2022 T001120 exp 5/2022 T001121 exp 5/2022 T001122 exp 5/2022 T001124 exp 5/2022 T001125 exp 5/2022 T001126 exp 5/2022 T001127 exp 5/2022 T001128 exp 5/2022 T001129 exp 5/2022 T001130 exp 5/2022 T001260 exp 5/2022 T001261 exp 5/2022 T900506 exp 4/2021 T900507 exp 4/2021 T900508 exp 4/2021 T900655 exp 5/2021 T900656 exp 5/2021 T900657 exp 5/2021 T900658 exp 5/2021 T900659 exp 5/2021 T900673 exp 5/2021 T900674 exp 5/2021 T901024 exp 7/2021 T901025 exp 7/2021 T901026 exp 7/2021 T901027 exp 7/2021 T901029 exp 7/2021 T901030 exp 7/2021 T901031 exp 7/2021 T901032 exp 7/2021 T901033 exp 7/2021 T901424 exp 10/2021 T901425 exp 10/2021 T901426 exp 10/2021 T901427 exp 10/2021 T901428 exp 10/2021 T901429 exp 10/2021 T901430 exp 10/2021 T901431 exp 10/2021 T901432 exp 10/2021 T901433 exp 10/2021 T901568 exp 10/2021 T901569 exp 10/2021 T901570 exp 11/2021 T901571 exp 11/2021 T901572 exp 11/2021 T901573 exp 11/2021 T901574 exp 11/2021 T901575 exp 11/2021 T901576 exp 11/2021 T901577 exp 11/2021

Where was it sold?

Distributed Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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15 Oct 2025Drug	CLASS II	Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
23 Jul 2025Drug	CLASS II	Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole	Dr. Reddy's Laboratories	Other	Nationwide
23 Apr 2025Drug	CLASS I	Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam	Dr. Reddy's Laboratories	Labeling Errors	Nationwide
18 Dec 2024Drug	CLASS III	Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor	Dr. Reddy's Laboratories	Potency & Assay	Nationwide

Other Atorvastatin recalls

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Reported	Class	Recall	Company	Reason	Where
22 Oct 2025Drug	CLASS II	Atorvastatin Calcium Tablets USP, 40 mg recalled by Ascend LaboratoriesAtorvastatin Calcium	Ascend Laboratories	Potency & Assay	Nationwide
22 Oct 2025Drug	CLASS II	Atorvastatin Calcium Tablets USP, 10 mg recalled by Ascend LaboratoriesAtorvastatin Calcium	Ascend Laboratories	Potency & Assay	Nationwide
22 Oct 2025Drug	CLASS II	Atorvastatin Calcium Tablets USP, 20 mg recalled by Ascend LaboratoriesAtorvastatin Calcium	Ascend Laboratories	Potency & Assay	Nationwide
22 Oct 2025Drug	CLASS II	Atorvastatin Calcium Tablets USP, 80 mg recalled by Ascend LaboratoriesAtorvastatin Calcium	Ascend Laboratories	Potency & Assay	Nationwide
9 Apr 2025Drug	CLASS II	Atorvastatin Calcium Tablets USP 40 mg recalled by Biocon PharmaAtorvastatin Calcium	Biocon Pharma	Potency & Assay	Nationwide