Drug recall: Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-129
FDA enforcement event 83908 is a drug recall by an individual recalling firm (name withheld) of Princeton, NJ, initiated 1 Oct 2019 and classified Class II, with 18 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 68% of the 362 drug enforcement events initiated in 2019 carry the same class.
Status: Completed. Initiation: voluntary: firm initiated.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Individual recalling firm (name withheld), Princeton, NJ. FDA names an individual as the recalling firm; this site does not publish people's names.
Reason for recall
"CGMP Deviations: Presence of NDMA impurity detected in product."
Distribution
"Product was distributed to major distributors throughout the United States who may have further distributed the product."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0168-2020 | Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-129-05) | N/A | Class II | Completed | 13 Nov 2019 |
| D-0169-2020 | Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OTC, NDC 150062076 UPC Code 078742089720 | N/A | Class II | Completed | 13 Nov 2019 |
| D-0170-2020 | Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 0363-0010-34), b.) 65 count bottles (NDC 0363-0010-61) , c.) 95 count bottles (NDC 0363-0010-62), d.) 200 count bottles (NDC 0363-0010-01) (Walgreens) OTC | N/A | Class II | Completed | 13 Nov 2019 |
| D-0171-2020 | Ranitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 130 count bottles (NDC 49035-404-13) c.) 220 count bottles (NDC 49035-404-65) (Walmart) OTC | N/A | Class II | Completed | 13 Nov 2019 |
| D-0172-2020 | Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 30142-505-34), b.) 50 count bottles (NDC 30142-505-50) (Kroger) OTC | N/A | Class II | Completed | 13 Nov 2019 |
| D-0173-2020 | Ranitidine Tablets, USP 75 mg, a.) 30 count bottles (NDC 69842-871-30) b.) 80 count bottles (NDC 69842-871-80) c.)160 count bottles (NDC 69842-871-37) (CVS) OTC | N/A | Class II | Completed | 13 Nov 2019 |
| D-0174-2020 | Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger) | N/A | Class II | Completed | 13 Nov 2019 |
| D-0175-2020 | Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC | N/A | Class II | Completed | 13 Nov 2019 |
| D-0176-2020 | Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) 220 count bottles (NDC 43598-808-65) (HCA) OTC. | N/A | Class II | Completed | 13 Nov 2019 |
| D-0177-2020 | Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 71713-203-02), b.)95 count bottles (NDC 71713-203-05) (Thirty Madison) OTC. | N/A | Class II | Completed | 13 Nov 2019 |
| D-0178-2020 | Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC. | N/A | Class II | Completed | 13 Nov 2019 |
| D-0179-2020 | Ranitidine Tablets, USP 150 mg, 40 count bottles, NDC 11673-849-40 (Target) OTC. | N/A | Class II | Completed | 13 Nov 2019 |
| D-0180-2020 | Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.) 100 count bottles (NDC 55111-130-01) | N/A | Class II | Completed | 13 Nov 2019 |
| D-0181-2020 | Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC) | N/A | Class II | Completed | 13 Nov 2019 |
| D-0182-2020 | Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC) | N/A | Class II | Completed | 13 Nov 2019 |
| D-0183-2020 | Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) OTC | N/A | Class II | Completed | 13 Nov 2019 |
| D-0184-2020 | Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) 50-count bottles (NDC 63868-480-50) (CDMA) OTC | N/A | Class II | Completed | 13 Nov 2019 |
| D-0185-2020 | Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC | N/A | Class II | Completed | 13 Nov 2019 |
Context
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "CGMP Deviations: Presence of NDMA impurity detected in product."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Product was distributed to major distributors throughout the United States who may have further distributed the product."
Is the recall still ongoing?
FDA lists the status as Completed. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.